Abstract:
OBJECTIVE:To evaluate the relative bioavailability of a new formulation containing 5 mg mosapride and 10 mg rabeprazole (T) and compare it with the branded formulations of both drugs co-administered in separate tablets (R) to meet the regulatory requirements of bioequivalence in Argentina. METHODS:A randomized-sequence, open-label, two-period crossover study was conducted on 24 healthy Caucasian volunteers in a fasting state. A single oral dose of either T or R formulations was followed by a 7-day washout period. Blood samples for mosapride were collected before administration (baseline) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 h after administration. Samples for rabeprazole were taken baseline and at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8 and 10 h after dosing. Mosapride and rabeprazole concentrations were determined using a validated LC-MS/MS method. Adverse events were monitored based on clinical parameters and volunteer reports. RESULTS:The geometric means (90% CI) C(max) for mosapride in T and R were 23.13 (20.05-39.45) and 23.09 (21.69-32.37) ng/mL, the AUC(0-)(t) were 70.80 (66.23-102.37) and 70.81 (66.35-93.26) ng h/mL and the AUC(0-∞) were 74.05 (69.29-106.11) and 74.98 (70.43-97.77) ng h/mL. For rabeprazole T and R the C(max) were 197.42 (186.12-239.91) and 195.50 (186.08-250.07) ng/mL, the AUC(0-)(t) were 294.90 (275.13-374.15) and 296.96 (280.11-387.89) ng h/mL and the AUC(0-∞) were 301.12 (280.78-380.82) and 304.07 (286.60-394.21), respectively. No differences were detected between the formulations. The T/R ratios (90% CI) for C(max), AUC(0-)(t) and AUC(0-∞) were 100.17% (82.35-121.84), 99.99% (87.58-114.16) and 98.77% (87.02-112.11) for mosapride, and 100.99% (85.14-119.77), 99.31% (84.74-116.38) and 99.03% (85.07-115.28) for rabeprazole. No subject complained of adverse events. CONCLUSIONS:In this single-dose study, the mosapride/rabeprazole tablets (test formulation) met the criterion for bioequivalence with the reference formulations. Study limitations include single-dose, open-label design, and a small sample of healthy volunteers.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Keller GA,Czerniuk P,Bertuola R,de Mena F,Simoni MV,Assefi AR,Di Girolamo Gdoi
10.1185/03007995.2011.624088subject
Has Abstractpub_date
2011-11-01 00:00:00pages
2203-11issue
11eissn
0300-7995issn
1473-4877journal_volume
27pub_type
杂志文章,随机对照试验abstract:OBJECTIVE:The Physician Payments Sunshine Act, enacted in 2010, is intended to increase the transparency of relationships between US physicians and teaching hospitals and manufacturers of drugs, biologics, and medical devices. We examined current opinion regarding the impact of the Sunshine Act on peer-reviewed medical...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2015.1131151
更新日期:2016-01-01 00:00:00
abstract:BACKGROUND:In TRITON-TIMI 38, patients with acute coronary syndromes were treated with prasugrel or clopidogrel, with aspirin, for a median of 14.5 (maximum of 15) months. Based on this trial, the EU label for prasugrel recommends treatment for up to 12 months and excludes patients with prior stroke/transient ischemic ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/03007995.2014.944638
更新日期:2014-11-01 00:00:00
abstract:OBJECTIVE:The Glucose and Lipid Assessment in Diabetes (GLAD) trial examined the dose-response relationship of the dual peroxisome proliferator-activated receptor (PPAR) alpha/gamma agonist tesaglitazar in type 2 diabetic patients. STUDY DESIGN:GLAD was a 12-week, multicenter, international, randomized, parallel-group...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/030079906x154169
更新日期:2006-12-01 00:00:00
abstract::This study evaluated the prognostic significance of several risk factors on the outcome of coronary heart disease (CHD) in 639 cardiovascular disease-free subjects with heterozygous familial hypercholesterolaemia (FH). During the 15-year follow-up, 53 (18%) men and 34 (9.8%) women had a CHD event (men vs women, p < 0....
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:
更新日期:2003-01-01 00:00:00
abstract::Three methods for the determination of azapropazone were studied for the analysis of blood plasma samples taken after oral administration of azapropazone. A gas chromatographic method was compared with two simple spectrophotometric assay methods and the effect of metabolites of the drug on each method is described. It...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997609109279
更新日期:1976-01-01 00:00:00
abstract:OBJECTIVE:To review the fatalities among children hospitalized with respiratory syncytial virus (RSV) infection, and identify factors leading to a fatal outcome. RESEARCH DESIGN AND METHODS:Review of literature identified from a structured search of PubMed (1966-2009) using the following Medical Subject Headings: resp...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2010.505126
更新日期:2010-09-01 00:00:00
abstract:OBJECTIVES:Pioglitazone hydrochloride (Actos † ) and rosiglitazone maleate (Avandia ‡ ) are members of the thiazolidinedione (TZD) class of oral anti-diabetic drugs (OADs) and are used to treat type 2 diabetes mellitus (T2DM). Greater beneficial effects on lipids have been demonstrated with pioglitazone, however. Study...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990802434874
更新日期:2008-11-01 00:00:00
abstract:OBJECTIVES:Many insulin-treated patients with type 2 diabetes (T2D) do not reach hemoglobin A1c (HbA1c) < 7%, but have clinically relevant HbA1c reductions. Using an integrated database (IDB) of 53 insulin lispro clinical trials and a real-world evidence (RWE) database of T2D patients initiating insulin therapy, an exp...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1396968
更新日期:2018-02-01 00:00:00
abstract:OBJECTIVE:To analyze the effect of brexpiprazole on metabolic parameters and body weight in adults with schizophrenia, including clinically relevant sub-groups of patients, based on data from two pivotal phase 3 studies (NCT01393613; NCT01396421) and a long-term extension study (NCT01397786). METHODS:The short-term st...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1080/03007995.2018.1498779
更新日期:2018-12-01 00:00:00
abstract:BACKGROUND:As of 2012, nearly 10% of Americans had diabetes mellitus. People with diabetes are at approximately double the risk of premature death compared with those in the same age groups without the condition. While the prevalence of diabetes has risen across all racial/ethnic groups over the past 30 years, rates ar...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2015.1029894
更新日期:2015-05-01 00:00:00
abstract:OBJECTIVE:Statin dose, adherence, and cardiovascular (CV) outcomes are important factors when considering switching statin therapies. The objective of the study was to compare CV event rates and risk in managed care patients receiving atorvastatin versus those switched to simvastatin from atorvastatin. METHODS:Patient...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2013.802229
更新日期:2013-07-01 00:00:00
abstract::An investigator-blind, parallel-group, multicentre study was undertaken to compare the efficacy and tolerability of once-daily, sustained-release (s-r) ibuprofen and diclofenac sodium in patients (mean age 59.8 years) suffering from painful osteoarthritis affecting chiefly the knee and/or hip. Patients attending eight...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/03007999609115224
更新日期:1996-01-01 00:00:00
abstract:BACKGROUND:The epidemiology and outcome of people hospitalised with a primary diagnosis of psoriasis has never been characterised previously in the United Kingdom. The aim of the study was to characterise the epidemiology of people admitted to hospital with a primary diagnosis of psoriasis. METHODS:Routine hospital da...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990802583563
更新日期:2008-12-01 00:00:00
abstract::Lowering cholesterol levels is a primary approach for reducing the risk of coronary heart disease (CHD), yet patients rarely achieve the lipid targets recommended by international guidelines. Although high rates of compliance and achievement of lipid targets have been reported in clinical trials, this situation is inf...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/030079903125002810
更新日期:2004-01-01 00:00:00
abstract::Fifty-two patients suffering from presumed viral pharyngeal infection or tonsillitis were treated with either benzydamine or placebo oral rinse as a gargle at 3-hourly intervals in a randomized double-blind study. Patients on the active preparation experienced faster resolution of pain and dysphagia and at 7 days 88% ...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998209112381
更新日期:1982-01-01 00:00:00
abstract:OBJECTIVE:To better understand depression's impact on family functioning from the perspectives of patients with major depressive disorder (MDD) and their partners; to develop and test patient and partner versions of a new self-reported measure, the Depression and Family Functioning Scale (DFFS), for use in clinical tri...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2012.658910
更新日期:2012-03-01 00:00:00
abstract::Aims: We sought to investigate the reasons for, and rates of, novel oral anticoagulant (DOAC) therapy discontinuation.Methods: This was an observational cohort study of patients with atrial fibrillation (AF) referred to a regional DOAC outpatient clinic between February 2013 and October 2017. The study population cons...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1725743
更新日期:2020-04-01 00:00:00
abstract::A clinical trial was undertaken in 50 patients with osteoarthritis of the knee to assess the therapeutic value of glycosaminoglycan-peptide complex in treatment. The first year consisted of a randomized, double-blind, placebo-controlled, parallel-group trial (25 patients in each group), after which all patients receiv...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998709112416
更新日期:1987-01-01 00:00:00
abstract::Zolmitriptan has been developed in an orally disintegrating tablet (ODT) formulation that rapidly dissolves on the tongue and can be taken quickly, conveniently and discreetly without fluid intake. In this 3-month, non-comparative, observational, post-marketing surveillance (PMS) study, 5,570 physicians prescribed the...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079905X46296
更新日期:2005-01-01 00:00:00
abstract:OBJECTIVE:With a growing number of studies and comparators in MRSA skin infections, a unified framework for comparing treatments is needed for health technology assessment (HTA). The objective was to systematically assess the success rates of common antimicrobial agents for the treatment of complicated skin and soft ti...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析,评审
doi:10.1185/03007995.2010.481251
更新日期:2010-07-01 00:00:00
abstract:OBJECTIVE:Significant race and ethnic disparities exist in diabetes-related health care. Using a nationally representative database, we sought to determine if use of thiazolidinediones (TZDs) differs by race and ethnicity. As a secondary objective, we sought to determine if race and ethnicity is associated with use of ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079906X167354
更新日期:2007-03-01 00:00:00
abstract::In order to assess the effect of ACTH on the adrenal cortex when used as a therapeutic or diagnostic agent, adrenocortical function was tested before and 2 hours after 0.5 mg tetracosactrin given intramuscularly in 31 healthy children, divided into 4 groups according to age and sex. Mean plasma cortisol levels were sh...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997709115283
更新日期:1977-01-01 00:00:00
abstract:OBJECTIVE:To assess whether maintenance of labor epidural analgesia using programmed intermittent epidural bolus (PIEB) is associated with reduced local anesthetic (LA) consumption, patient-controlled epidural analgesia (PCEA) use, and rescue analgesia requirements compared to continuous epidural infusion (CEI). RESEA...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2016.1181619
更新日期:2016-08-01 00:00:00
abstract:OBJECTIVE:To investigate the effect of fenofibrate on sleep apnoea indices. METHODS:Proof-of-concept study comprising a placebo run-in period (1 week, 5 weeks if fibrate washout was required) and a 4-week randomized, double-blind treatment period. Thirty-four subjects (mean age 55 years, body mass index 34 kg/m 2 , fa...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/03007991003693581
更新日期:2010-05-01 00:00:00
abstract::The position statement on the management of hyperglycemia in patients with type 2 diabetes mellitus issued in 2012 by the American Diabetes Association and the European Association for the Study of Diabetes contains significant improvements over the 2009 version, including an emphasis on patient-centered care, enhance...
journal_title:Current medical research and opinion
pub_type: 评论,杂志文章
doi:10.1185/03007995.2013.798637
更新日期:2013-07-01 00:00:00
abstract::A double-blind, parallel-group study was carried out to compare the efficacy and tolerability of a controlled-release tablet formulation of trazodone with the standard trazodone tablet. Three hundred and forty-seven general practice patients with depressive symptoms were recruited into the trial. Patients were randoml...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/03007999009111497
更新日期:1990-01-01 00:00:00
abstract:OBJECTIVE:The aim of the study was to evaluate the effect of gliclazide modified release (MR) treatment on adiponectin, interleukin 6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha) plasma concentrations in type 2 diabetic patients. RESEARCH DESIGN AND METHODS:24 randomly selected type 2 diabetic patients, aged 61...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/030079906X132424
更新日期:2006-10-01 00:00:00
abstract::The efficacy and safety of etodolac (Ultradol) and acetaminophen plus codeine [A + C (Tylenol #3)] in controlling post-surgical pain were compared in an open-label, randomized, parallel-group outpatient study. Patients who were voluntarily having a vasectomy performed for sterilization were assigned to receive either ...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007999709113329
更新日期:1997-01-01 00:00:00
abstract:OBJECTIVE:The prevalence of non-steroidal anti-inflammatory drug (NSAID) and concurrent gastroprotective agent (GPA) use in the US is not known. As such, the prevalence of GPA use among arthritis patients taking NSAIDs was examined. METHODS:Men and women aged ≥ 40 with self-reported arthritis and members of a web-base...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/03007995.2013.781017
更新日期:2013-05-01 00:00:00
abstract:INTRODUCTION:This brief review describes conservative treatment methods for pelvic venous congestion. Therapy options: The authors present an analysis of the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs), ergot alkaloid derivatives, hormonal agents, venoprotective agents, and compression therapy in the trea...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2017.1302414
更新日期:2017-06-01 00:00:00