Relative Bioavailability of Silybin A and Silybin B From 2 Multiconstituent Dietary Supplement Formulations Containing Milk Thistle Extract: A Single-dose Study.

Abstract:

PURPOSE:The purpose of this study was to compare the bioavailability between 2 milk thistle-containing dietary supplements, Product B and IsaGenesis, in healthy volunteers. METHODS:Bioavailability between Product B, originally formulated as a powdered capsule, and IsaGenesis, reformulated as a soft gel, were compared by measuring silybin A and silybin B as surrogate pharmacokinetic markers for differences in absorption and bioavailability. For this randomized, open-label, crossover pharmacokinetic study, 12 healthy volunteers consumed a single-dose serving of each supplement separated by at least a 7-day washout period. Serial blood samples were obtained at 0, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours and analyzed via LC-MS/MS. FINDINGS:Rapid absorption and elimination of silybin A and silybin B have been observed after oral administration of both Product B and IsaGenesis. However, the absorption rate and extent, as indicated by mean the Cmax and mean plasma AUC, were significantly higher for the IsaGenesis soft gel formulation. The dose-corrected mean Cmax was 365% and 450% greater for silybin A and B, respectively, relative to powdered Product B. The time to Tmax was reached, on average, at least 1 hour earlier with IsaGenesis relative to Product B for both silybin A and silybin B. IMPLICATIONS:The IsaGenesis soft gel formulation provided substantially greater absorption and bioavailability of silybin A and silybin B relative to the powdered Product B supplement. ClinicalTrials.gov Identifier: NCT02529605.

journal_name

Clin Ther

journal_title

Clinical therapeutics

authors

Li WY,Yu G,Hogan RM,Mohandas R,Frye RF,Gumpricht E,Markowitz JS

doi

10.1016/j.clinthera.2017.11.013

subject

Has Abstract

pub_date

2018-01-01 00:00:00

pages

103-113.e1

issue

1

eissn

0149-2918

issn

1879-114X

pii

S0149-2918(17)31104-9

journal_volume

40

pub_type

杂志文章,随机对照试验
  • A 2-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, phase III trial comparing the efficacy of oxymorphone extended release and placebo in adults with pain associated with osteoarthritis of the hip or knee.

    abstract:BACKGROUND:Oxymorphone extended release (ER) is a tablet formulation of the mu-opioid agonist oxymorphone designed to achieve a low peak-to-trough fluctuation in plasma concentrations over a 12-hour dosing period. OBJECTIVE:This study compared the analgesic efficacy, dose response, and tolerability of 3 doses of oxymo...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.clinthera.2006.03.008

    authors: Kivitz A,Ma C,Ahdieh H,Galer BS

    更新日期:2006-03-01 00:00:00

  • The financial implications for Medicare of greater use of peritoneal dialysis.

    abstract:BACKGROUND:Although annual per-person health care costs for patients with end-stage renal disease (ESRD) on in-center hemodialysis greatly exceed those for patients on peritoneal dialysis (PD), which is a home dialysis therapy, current use of PD remains low. In April 2008, the Centers for Medicare & Medicaid Services i...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2009.04.004

    authors: Neil N,Guest S,Wong L,Inglese G,Bhattacharyya SK,Gehr T,Walker DR,Golper T

    更新日期:2009-04-01 00:00:00

  • Management of impotence. I. Psychological considerations.

    abstract::In the past decade surgeons and sex therapists have given an enormous amount of attention to and assistance for men's sexual problems. Now pharmacological help, although controversial, is also available, both informally and from physicians. Sexual disorders afflict men in all walks of life, be they executives or windo...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:

    authors: Renshaw DC

    更新日期:1987-01-01 00:00:00

  • Multidisciplinary management of chronic heart failure: principles and future trends.

    abstract:PURPOSE:Globally, the management of chronic heart failure (CHF) challenges health systems. The high burden of disease and the costs associated with hospitalization adversely affect individuals, families, and society. Improved quality, access, efficiency, and equity of CHF care can be achieved by using multidisciplinary...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:10.1016/j.clinthera.2015.08.021

    authors: Davidson PM,Newton PJ,Tankumpuan T,Paull G,Dennison-Himmelfarb C

    更新日期:2015-10-01 00:00:00

  • Conventional and sustained-release procainamide: update on pharmacology and clinical use.

    abstract::Hemodynamic and electrophysiologic effects of procainamide, the pharmacokinetic properties of conventional and sustained-release forms of the drug, guidelines for its administration and dosage, and contraindications for and adverse effects of its use are outlined. A review of clinical studies of procainamide therapy c...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:

    authors: Anderson JL

    更新日期:1985-01-01 00:00:00

  • Prophylactic midazolam and clonidine for emergence from agitation in children after emergence from sevoflurane anesthesia: a meta-analysis.

    abstract:BACKGROUND:Emergence agitation (EA) after emergence from sevoflurane anesthesia is a common phenomenon in children. The efficacy of prophylactic midazolam or clonidine in preventing EA is controversial. OBJECTIVE:We performed a meta-analysis of clinical trials of the 2 drugs to evaluate their ability to prevent EA in ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析,评审

    doi:10.1016/j.clinthera.2013.08.016

    authors: Zhang C,Li J,Zhao D,Wang Y

    更新日期:2013-10-01 00:00:00

  • Electrical Muscle Stimulation Induces an Increase of VEGFR2 on Circulating Hematopoietic Stem Cells in Patients With Diabetes.

    abstract:PURPOSE:External electric muscle stimulation (EMS) of the thigh muscles was found to reduce pain resulting from diabetic neuropathy (DN), a vascular complication of diabetes. This study investigated circulating hematopoietic stem cells (HSCs) after EMS treatment. Impaired function of HSCs and the subpopulation endothel...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2017.05.340

    authors: Hidmark A,Spanidis I,Fleming TH,Volk N,Eckstein V,Groener JB,Kopf S,Nawroth PP,Oikonomou D

    更新日期:2017-06-01 00:00:00

  • Patients' and physicians' perceptions of the travoprost dosing aid: an open-label, multicenter study of adherence with prostaglandin analogue therapy for open-angle glaucoma or ocular hypertension.

    abstract:OBJECTIVE:This study describes patients' and physicians' perceptions of issues related to dosing adherence with topical therapies for lowering intraocular pressure before and after use of the travoprost dosing aid (Travatan Dosing Aid, Alcon Research Ltd., Fort Worth, Texas). METHODS:The study had an open-label, multi...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.1016/j.clinthera.2006.11.001

    authors: Flowers B,Wand M,Piltz-Seymour J,Berke SJ,Day D,Teague J,Smoot TM,Landry TA,Bergamini MV,Mallick S,Travatan Dosing Aid Study Group.

    更新日期:2006-11-01 00:00:00

  • Prevalence and correlates of potentially inappropriate prescribing among ambulatory older patients in the year 2001: comparison of three explicit criteria.

    abstract:OBJECTIVES:The aims of this study were to determine the prevalence of prescribing potentially inappropriate medications (PIMs) based on the 2002 Beers criteria among ambulatory patients aged > or =65 years, to compare PIM prevalence rates based on the 1997 Beers criteria and Zhan criteria with the rate obtained using t...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2005.01.009

    authors: Viswanathan H,Bharmal M,Thomas J 3rd

    更新日期:2005-01-01 00:00:00

  • Effects of 1 year of treatment with pioglitazone or rosiglitazone added to glimepiride on lipoprotein (a) and homocysteine concentrations in patients with type 2 diabetes mellitus and metabolic syndrome: a multicenter, randomized, double-blind, controlled

    abstract:BACKGROUND:Although the metabolic effects of the thiazolidinediones have been well studied, there is a lack of comparative data on their effects on certain cardiovascular risk factors, such as elevated plasma levels of lipoprotein (a) (Lp[a]) and homocysteine (Hcy). OBJECTIVE:This study compared the effects of pioglit...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.clinthera.2006.05.012

    authors: Derosa G,Cicero AF,D'Angelo A,Gaddi A,Ciccarelli L,Piccinni MN,Salvadeo SA,Pricolo F,Ferrari I,Gravina A,Ragonesi PD

    更新日期:2006-05-01 00:00:00

  • Randomized, open-label, single-dose, crossover, relative bioavailability study in healthy adults, comparing the pharmacokinetics of rabeprazole granules administered using soft food or infant formula as dosing vehicle versus suspension.

    abstract:BACKGROUND:A sprinkle capsule formulation containing enteric-coated, delayed-release rabeprazole granules is being developed for the treatment of children with gastrointestinal reflux disease. The granules are designed to be mixed with vehicles that facilitate delivery to children, who may be unable to swallow solid fo...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.clinthera.2012.06.008

    authors: Thyssen A,Solanki B,Treem W

    更新日期:2012-07-01 00:00:00

  • Overview of US Maternal Mortality Policy.

    abstract::The United States maternal mortality rate has been rising for many years putting the US out of step with peer countries. There are many complex reasons for the rise in maternal deaths and recent data has demonstrated that there is a disproportionate risk for women of color. This article provides an overview of current...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:10.1016/j.clinthera.2020.01.015

    authors: Villavicencio JC,McHugh KW,Edmonds BT

    更新日期:2020-03-01 00:00:00

  • Plasma concentrations of flecainide acetate, a new antiarrhythmic agent, in humans.

    abstract::Flecainide, a new antiarrhythmic agent, was given to eight healthy men to ascertain plasma drug levels and to assess tolerance for the drug. Each subject received a single intravenous (IV) dose (0.5, 1, 1.5, or 2 mg/kg) of flecainide, and plasma levels of unchanged flecainide were measured by gas-liquid chromatography...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:

    authors: Conard GJ,Carlson GL,Frost JW,Ober RE,Leon AS,Hunninghake DB

    更新日期:1984-01-01 00:00:00

  • Insulin glargine.

    abstract:BACKGROUND:In diabetes mellitus, the clinical goal of intensive glycemic control (lowering blood glucose concentrations to normal or near-normal levels) has been hindered by the lack of insulin regimens that duplicate the basal-bolus secretion of insulin by the healthy pancreas. In particular, intensive therapy has bee...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:10.1016/s0149-2918(01)80148-x

    authors: Campbell RK,White JR,Levien T,Baker D

    更新日期:2001-12-01 00:00:00

  • Meta-analysis of venous thromboembolism prophylaxis in medically Ill patients.

    abstract:BACKGROUND:Venous thromboembolism (VTE) prophylaxis in medically ill patients has received a level 1A recommendation in previously published clinical guidelines. Pharmacologic prophylaxis for VTE includes unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and fondaparinux. Few direct comparisons between...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析,评审

    doi:10.1016/j.clinthera.2007.11.015

    authors: Kanaan AO,Silva MA,Donovan JL,Roy T,Al-Homsi AS

    更新日期:2007-11-01 00:00:00

  • Mononitrates: defining the ideal long-acting nitrate.

    abstract::As a result of recent advances in our understanding of the role of nitric oxide and endothelial-derived relaxing factor (EDRF) in vascular control, physicians now have the potential to overcome the loss of EDRF effect by administering nitrates. Nitrates are converted to nitric oxide, resulting in vasodilator effects t...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:

    authors: Frishman WH,Amsterdam E,Glasser SP,Thadani U

    更新日期:1994-03-01 00:00:00

  • Real-time Assessment of the Development and Function of the Placenta Across Gestation to Support Therapeutics in Pregnancy.

    abstract::The placenta is vital to the health and development of the fetus, serving to deliver oxygen and nutrients, facilitate the removal of waste products, and provide a barrier to pathogens and other harmful substances present in the maternal circulation. When these processes fail to operate normally, they can lead to compl...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2020.11.002

    authors: Weinberg DH

    更新日期:2020-11-24 00:00:00

  • Tolerability and efficacy of long-term daily administration of indomethacin for moderate to severe chronic arthritic disorders.

    abstract::The long-term tolerability and efficacy of indomethacin were evaluated in a retrospective study of 67 patients with moderate to severe rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis who took the drug daily for periods ranging from three to 20 years. Only patients who had not experienced side effects d...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:

    authors: Lockie LM

    更新日期:1986-01-01 00:00:00

  • Management of refractory essential thrombocythemia with anagrelide in a patient undergoing hemodialysis.

    abstract:BACKGROUND:Management of essential thrombocythemia (ET) in high-risk patients is difficult because high platelet numbers can lead to vascular occlusive events and bleeding. Therapeutic interventions in ET are limited to hydroxyurea and anagrelide; however, in Europe, anagrelide is contraindicated in patients with chron...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2009.11.006

    authors: Mesquita Mdo C,Sol EB,Malarme M,Noubouossie D,Demulder AC

    更新日期:2009-11-01 00:00:00

  • Antimicrobial-resistant Pseudomonas aeruginosa and Acinetobacter baumannii From Patients With Hospital-acquired or Ventilator-associated Pneumonia in Vietnam.

    abstract:PURPOSE:Multidrug-resistant bacterial pathogens are becoming a significant problem worldwide. Acinetobacter baumannii and Pseudomonas aeruginosa are problematic multidrug-resistant pathogens. This multicenter study in Vietnam determined the level of resistance to antimicrobial agents used to treat A baumannii and P aer...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.clinthera.2016.07.172

    authors: Biedenbach DJ,Giao PT,Hung Van P,Su Minh Tuyet N,Thi Thanh Nga T,Phuong DM,Vu Trung N,Badal RE

    更新日期:2016-09-01 00:00:00

  • Randomized, double-blind, placebo-controlled comparison of the action of orlistat, fluvastatin, or both an anthropometric measurements, blood pressure, and lipid profile in obese patients with hypercholesterolemia prescribed a standardized diet.

    abstract:OBJECTIVE:The aim of this study was to assess obese patients with hypercholesterolemia whom were prescribed a standardized diet, comparing the action of orlistat, fluvastatin, orlistat with fluvastatin, and placebo on anthropometric measurements, blood pressure (BP), and lipid profile. METHODS:This was a 1-year, rando...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/s0149-2918(03)80070-x

    authors: Derosa G,Mugellini A,Ciccarelli L,Fogari R

    更新日期:2003-04-01 00:00:00

  • Retrospective review of the relationship between weight change and demographic factors following initial depot medroxyprogesterone acetate injection in adolescents.

    abstract:BACKGROUND:Depot medroxyprogesterone acetate (DMPA) is an effective (<1% annual failure rate) contraceptive administered by intramuscular injection every 3 months. DMPA is an increasingly popular contraceptive choice for adolescents, yet its use is associated with weight gain as well as subsequent nonadherence and long...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:10.1016/j.clinthera.2011.02.008

    authors: Gerlach LS,Saldaña SN,Wang Y,Nick TG,Spigarelli MG

    更新日期:2011-02-01 00:00:00

  • Effects of food intake on the pharmacokinetic properties of dalcetrapib: findings from three phase I, single-dose crossover studies in healthy volunteers.

    abstract:BACKGROUND:Preclinical studies have reported that the relative bioavailability of dalcetrapib, a modulator of cholesteryl ester transfer protein (CETP) inhibitor activity, was ∼60% higher when administered in the fed state compared with the fasting state. OBJECTIVE:This article reports on 3 studies conducted to assess...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.clinthera.2011.05.046

    authors: Derks M,Kawamura H,Abt M,Meneses-Lorente G,Phelan M,Ishikawa T

    更新日期:2011-06-01 00:00:00

  • Oral contraceptives: the state of the art.

    abstract::This paper presents a state-of-the-art review of oral contraceptives (OCs), termed one of the epochal developments of modern times. OCs have had both direct and indirect influences on moral, social, and cultural values and on the interaction of population resources and the environment. In recent years there has been...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:

    authors: Greenblatt RB

    更新日期:1985-01-01 00:00:00

  • Cost of Bleeding-related Episodes in Adult Patients With Primary Immune Thrombocytopenia: A Population-based Retrospective Cohort Study of Administrative Claims Data for Commercial Payers in the United States.

    abstract:PURPOSE:We estimated the real-world costs of bleeding-related episodes (BREs) in adults with primary immune thrombocytopenia (ITP). METHODS:This retrospective cohort study used the MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases. We identified adult patients...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2017.01.023

    authors: Lin J,Zhang X,Li X,Chandler D,Altomare I,Wasser JS,Cetin K

    更新日期:2017-03-01 00:00:00

  • Cisapride and metoclopramide in the treatment of gastroesophageal reflux disease.

    abstract::In a double-blind, randomized study, the clinical effects of 5 mg and 10 mg of cisapride three times daily were compared with those of 10 mg of metoclopramide three times daily in 114 patients with symptoms of gastroesophageal reflux, mainly diurnal and nocturnal heartburn and regurgitation. The symptoms significantly...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:

    authors: Arabehety JT,Leitão OR,Fassler S,Olarte M,Serrano C

    更新日期:1988-01-01 00:00:00

  • Nisoldipine versus isosorbide dinitrate in coronary heart disease: results of a double-masked study.

    abstract::The efficacy and tolerability of a twice-daily dose of 5 mg of nisoldipine versus 40 mg of sustained-release isosorbide dinitrate (ISDN) were compared in a randomized, double-masked study in 91 patients. During the 21-day treatment period, the mean time taken during bicycle ergometry to the appearance of an ST segment...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/s0149-2918(96)80025-7

    authors: Heublein B,Amende I,Blanke PM,Baunack-Frost AR,Breuer HW

    更新日期:1996-05-01 00:00:00

  • Impact of ezetimibe coadministered with statins on cardiovascular events following acute coronary syndrome: a 3-year population-based retrospective cohort study in Taiwan.

    abstract:BACKGROUND:Conflicting results using the combination of ezetimibe and statins to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS) have been reported. OBJECTIVE:The aim of this work was to assess the effectiveness of ezetimibe coadministered with statins in reducing cardiovascular...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2011.08.002

    authors: Lin CF,Gau CS,Wu FL,Hsiao FY,Bai CH,Shen LJ

    更新日期:2011-09-01 00:00:00

  • Lessons learned with ambulatory blood pressure monitoring: a focus on ramipril.

    abstract::Ambulatory blood pressure monitoring (ABPM) has been available since the mid-1970s. Widespread use of ABPM in research settings has led to an appreciation of its advantages and disadvantages. ABPM is a valuable research tool because of its ability to evaluate the duration and consistency of action with new antihyperte...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:

    authors: Burris JF

    更新日期:1993-05-01 00:00:00

  • New insights and treatments: opiate withdrawal and cocaine addiction.

    abstract::Basic research in the neurosciences has led to a theory of opiate withdrawal involving endogenous opioid peptides and hyperactive norepinephrine neurons. This theory predicts the efficacy of clonidine, a nonopiate agent, in the management of opiate withdrawal. Clonidine, which offers numerous advantages over methadone...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:

    authors: Gold MS,Dackis CA

    更新日期:1984-01-01 00:00:00