Abstract：
PURPOSE:Megestrol acetate oral suspension is an appetite stimulant indicated for cachexia. It is available in a conventional formulation and as a nanocrystal dispersion. The aim of this study was to compare the tolerability and pharmacokinetics of these formulations under fed conditions in healthy Korean volunteers. METHODS:This was a randomized, single-dose, 3-treatment, 3-period, 6-sequence, crossover study in healthy Korean volunteers. In each period, participants received single oral doses of conventional formulation 800 mg/20 mL (reference), nanocrystal dispersion 650 mg/5.2 mL (test 1), and nanocrystal dispersion 675 mg/5.4 mL (test 2) after a high-calorie, high-fat meal. The periods were separated by a washout period of 14 days. Serial blood samples were collected up to 120 hours after dosing. The plasma concentrations of megestrol acetate were determined with a validated LC-MS/MS method. Pharmacokinetic parameters were obtained by noncompartmental analysis. Tolerability was assessed by physical examinations, vital signs, clinical laboratory test results, and electrocardiograms. FINDINGS:Thirty-eight healthy volunteers completed the study. The geometric mean ratios of the AUC(last) and C(max) for test 1/reference were 0.88 (90% CI, 0.84-0.92) and 1.07 (90% CI, 0.99-1.15), respectively. The geometric mean ratios of the AUC(last) and C(max) for test 2/reference were 0.88 (90% CI, 0.84-0.93) and1.03 (90% CI, 0.96-1.10), respectively. All formulations were well tolerated. IMPLICATIONS:The pharmacokinetic characteristics and tolerability of the 2 megestrol acetate formulations are similar in fed volunteers and suggest no relevant difference in tolerability. ClinicalTrials.gov identifier: NCT01342055.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Kim YH,Choi HY,Jin S,Noh YH,Kim MJ,Park HJ,Lim HS,Bang K,Lee SH,Bae KSdoi
10.1016/j.clinthera.2014.09.022subject
Has Abstractpub_date
2015-02-01 00:00:00pages
439-47issue
2eissn
0149-2918issn
1879-114Xpii
S0149-2918(14)00614-6journal_volume
37pub_type
杂志文章,随机对照试验abstract：BACKGROUND:The continuing increase in the rate of penicillin and cephalosporin resistance among respiratory pathogens and of cross-resistance to macrolide antibiotics has led to the recommendation that fluoroquinolone antibiotics be used to treat high-risk patients with community-acquired pneumonia (CAP) and acute bact...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/S0149-2918(00)89007-4
更新日期：2000-04-01 00:00:00
abstract：BACKGROUND:Oral bisphosphonates are well established for the treatment and prevention of postmenopausal osteoporosis; however, they are poorly absorbed from the gastrointestinal (GI) tract and have been associated with GI adverse events. Thus, current dosing guidelines recommend that the patient not eat or lie down for...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/s0149-2918(03)90005-1
更新日期：2003-01-01 00:00:00
abstract：BACKGROUND:Changing etiologic patterns and the growing problem of antimicrobial resistance, particularly an increase in macrolide-resistant pneumococcal bacteremia, are causing physicians to adopt new approaches to the treatment of community-acquired pneumonia (CAP). OBJECTIVE:The relative efficacy and tolerability of...
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：10.1016/s0149-2918(02)80034-0
更新日期：2002-08-01 00:00:00
abstract：:This multicenter, randomized, double-blind study compared the efficacy and tolerability of ondansetron 8 mg twice daily for 3 days with placebo in preventing nausea and vomiting in 81 patients receiving cyclophosphamide-doxorubicin-based chemotherapy. The first dose of study drug was administered 30 minutes before the...
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：10.1016/0149-2918(95)80087-5
更新日期：1995-11-01 00:00:00
abstract：PURPOSE:This study aimed to review and summarize clinical trial data, updated guidelines, and expert opinions on the recommendations for drug holidays in patients being treated for osteoporosis. METHODS:Three unique PubMed searches using the terms osteoporosis drug holiday, osteoporosis discontinuation, and osteoporos...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2015.03.023
更新日期：2015-07-01 00:00:00
abstract：BACKGROUND:Plasma concentrations of cloxacillin have been found to vary as much as 20-fold among individuals receiving the same oral dose. There is evidence that cloxacillin may be a substrate for P-glycoprotein, suggesting that polymorphisms in the ABCB1 gene may be a contributing factor to the observed variability in...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2009.05.014
更新日期：2009-05-01 00:00:00
abstract：:Eleven patients suffering from WHO stage II essential arterial hypertension were treated with the combination of labetalol plus chlorthalidone in the reciprocal ratio of 10:1 in the form of once-a-day administration in the morning. The dosage was individualized on the basis of hypotensive response and side effects unt...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1981-01-01 00:00:00
abstract：PURPOSE:Antihypertensive drugs are prescribed to patients with chronic kidney disease (CKD) for their cardioprotective and renoprotective effects. Nationally representative information on the use of antihypertensive drugs among CKD patients is limited. The purpose of this study was to assess the utilization patterns of...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2014.11.011
更新日期：2015-01-01 00:00:00
abstract：:Two studies were conducted to determine the prevalence of Chlamydia trachomatis in the urine and cervical exudates of women with genitourinary symptoms. In the first study, 873 women attending the World Health Organization-Sexually Transmitted Disease Center of the Alfred Fournier Institute, in Paris, were examined. I...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1986-01-01 00:00:00
abstract：PURPOSE:ME-401 is a novel selective inhibitor of phosphatidylinositol 3 kinase p110δ, an enzyme often found overexpressed and overactive in B-cell malignancies. The current study was performed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending oral doses of ME-401 in healthy ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2018.09.006
更新日期：2018-11-01 00:00:00
abstract：:A comparison of single-agent antimicrobial therapy in the treatment of patients with perforated or gangrenous appendicitis and peritonitis was performed in a double-blind, randomized, prospective trial. Pathologic documentation of advanced appendicitis and positive intraoperative specimen cultures were required for in...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：
更新日期：1990-01-01 00:00:00
abstract：PURPOSE:The goal of this study is to identify and compare all direct costs of intravenous and subcutaneous rituximab given to patients with diffuse large B-cell lymphoma in the Netherlands. METHODS:Using a prospective, observational, bottom-up microcosting study, we collected primary data on the direct medical costs o...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2017.05.342
更新日期：2017-06-01 00:00:00
abstract：:The effects of treatment with epalrestat, an aldose reductase inhibitor, on peripheral neuropathy were studied in 45 patients with non-insulin-dependent diabetes mellitus (NIDDM). Epalrestat 150 mg three times daily was given for 24 weeks. Subjective symptoms, such as spontaneous pain in the lower extremities and numb...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：10.1016/0149-2918(95)80111-1
更新日期：1995-05-01 00:00:00
abstract：BACKGROUND:Type 2 diabetes mellitus is twice as prevalent in African Americans and Hispanic Americans as in non-Hispanic whites. However, the effectiveness and safety profile of rosiglitazone maleate used as combination therapy with sulfonylureas in the management of diabetes and its effect on cardiovascular disease (C...
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.2007.09.011
更新日期：2007-09-01 00:00:00
abstract：PURPOSE:In China, dabigatran and rivaroxaban are the only approved non-vitamin K antagonist oral anticoagulants for the treatment of atrial fibrillation (AF). The goal of this article was to assess the cost-effectiveness of dabigatran versus rivaroxaban for the prevention of stroke and systemic embolism in Chinese pati...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2019.11.011
更新日期：2020-01-01 00:00:00
abstract：:Forty women with moderate to severe primary dysmenorrhea participated in a two-month, double-blind, crossover trial comparing ketoprofen with mefenamic acid. Treatment with ketoprofen provided rapid and marked pain relief similar to that afforded by mefenamic acid. This improvement in symptoms was accompanied by an am...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：
更新日期：1986-01-01 00:00:00
abstract：:Chancroid, the third most prevalent venereal disease in Thailand, was treated with a single 2-gm dose of spectinomycin, or two tablets of co-trimoxazole (trimethoprim-sulfamethoxazole) twice daily for seven days. The differences in cure rates between the two groups were statistically significant. The chancroidal ulcer...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：
更新日期：1990-05-01 00:00:00
abstract：:We studied the effects of atropine and pirenzepine on acid secretion induced by electrical vagal stimulation (EVS) and on healing of gastric ulcers after mucosal excision in rats. Both atropine (50, 125, and 250 micrograms/kg/hr) and pirenzepine (2.5, 5.0, and 12.5 mg/kg/hr), administered intraperitoneally, inhibited ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1985-01-01 00:00:00
abstract：BACKGROUND:Dementia is a cerebral disorder resulting in a progressive deterioration of intellectual function that compromises the patient's ability to function. The diagnostic criteria for dementia are primarily clinical and are based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. The Hac...
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：10.1016/S0149-2918(00)80056-9
更新日期：2000-07-01 00:00:00
abstract：BACKGROUND:The Lescol Intervention Prevention Study (LIPS) was a multinational randomized controlled trial that showed a 47% reduction in the relative risk of cardiac death and a 22% reduction in major adverse cardiac events (MACEs) from the routine use of fluvastatin, compared with controls, in patients undergoing per...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2005.09.012
更新日期：2005-09-01 00:00:00
abstract：OBJECTIVES:This study evaluated adherence to anti-inflammatory controller medication for asthma in a French population. METHODS:This was an observational cohort study that employed data from the health insurance database for the Aquitaine region of France. Eligible subjects were aged between 15 and 45 years and had > ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2008.06.011
更新日期：2008-01-01 00:00:00
abstract：:Congestive heart failure (CHF) afflicts more than 4.6 million people in the United States and increases at a rate of 400,000 newly diagnosed patients per year. With more than 1.5 million hospital admissions per year attributed to CHF, it is the number one cause of hospitalization. Hospital length of stay (LOS) is one ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(96)80223-2
更新日期：1996-07-01 00:00:00
abstract：:Oral rehydration therapy (ORT) has had a dramatic global impact. The worldwide consequences of this therapy are discussed in four categories: (1) adoption of ORT as the primary therapy for acute dehydrating diarrhea; (2) establishment of national ORT programs; (3) scientific knowledge gained from studies into intestin...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：
更新日期：1990-01-01 00:00:00
abstract：BACKGROUND:PHX1149 is a dipeptidyl peptidase-4 (DPP4) inhibitor that is currently in clinical development for the treatment of type 2 diabetes mellitus. PHX1149 is a small (molecular weight = 241.16 Da), highly water-soluble (>2 g/mL), orally active molecule with a selectivity index of 15- to 319-fold relative to those...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2007.08.005
更新日期：2007-08-01 00:00:00
abstract：:The history of drug safety monitoring, or pharmacovigilance, has been an interesting one. Despite many and ongoing changes, it has typically been characterized by a rather slow-moving and reactive progression. Pharmacovigilance has always lagged behind other fields and industries and has been slow to adapt to new appr...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2018.10.012
更新日期：2018-12-01 00:00:00
abstract：PURPOSE:Saliva is a reliable, noninvasive, and cost-effective alternative to biomarkers measured in other biological fluids. Within certain populations, saliva sampling may be difficult because of insufficient saliva flow, which may compromise disease diagnosis or research integrity. Methods to improve flow rates (eg, ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2015.02.015
更新日期：2015-03-01 00:00:00
abstract：:Allylestrenol was used to treat 375 women with threatened pregnancies. Results show that this drug is capable of maintaining pregnancy in a large series of ambulant patients and is safe for both mother and child. Allylestrenol does not maintain pregnancy if placental dysfunction is present, however. Newborns whose mot...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1980-01-01 00:00:00
abstract：BACKGROUND:Tetanus-diphtheria-acellular pertussis (Tdap) was licensed in the United States in 2005 to be given in place of tetanus-diphtheria (Td) for single use in adolescents. OBJECTIVES:This analysis was conducted to determine vaccination coverage with Td and Tdap among adolescents in the United States aged 13 to 1...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2010.07.016
更新日期：2010-08-01 00:00:00
abstract：PURPOSE:In critical burn patients, the pharmacokinetic parameters (absorption, distribution, metabolism, and excretion) of many classes of drugs, including antibiotics, are altered. The aim of this study was to compare 2 groups of burn patients undergoing treatment for health care-associated infections with and without...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2017.06.008
更新日期：2017-08-01 00:00:00
abstract：:The objective of this study was to assess a weight-based heparin (WBH) nomogram (80-U/kg bolus, 18-U/kg-per-hour initial infusion) and determine its clinical performance and impact on resource utilization. All patients treated with heparin for venous thromboembolism or unstable angina during a 15-week study period wer...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：10.1016/s0149-2918(98)80133-1
更新日期：1998-07-01 00:00:00
