Abstract:
BACKGROUND:Mycophenolate mofetil (MMF) is an immunosuppressant indicated for prophylaxis of acute organ transplant rejection. Generic MMF is less costly than the branded product, but European regulatory authorities require bioequivalence studies for the marketing of generics. OBJECTIVES:The aims of the 2 studies reported were to assess the dissolution and bioavailability of a generic (test) and branded (reference) formulation of MMF 500 mg. METHODS:An in vitro analytical dissolution profile test was conducted comparing 500 mg MMF test drug with a reference drug. A separate single-dose, randomized, open-label, 2-way crossover study involving fasting, healthy, adult male volunteers was conducted. Two study periods-1 test drug period and 1 reference drug period-were separated by a 14-day washout period. Blood samples were collected for up to 60 hours after drug administration for the determination of MMF and mycophenolic acid (MPA) pharmacokinetics. Concentrations of the analytes were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method; pharmacokinetic parameters were calculated using noncompartmental analysis; C(max), AUC(0-t), and AUC(0-∞) were the primary evaluation criteria. Bioequivalence was assumed if the 90% confidence intervals (CIs) for the test/reference ratios of natural logarithm transformed values (obtained using ANOVA) were between 80% and 125%, per European regulations for bioequivalence. Tolerability was monitored throughout the study. RESULTS:The dissolution profiles of the test drug matched those of the reference drug at 4 pH levels. In the bioequivalence study, a total of 126 male subjects were dosed, and 117 subjects completed the study. The 90% CIs for MPA were C(max), 94.13% to 116.46%; AUC(0-t), 98.26% to 102.36%; and AUC(0-∞), 97.85% to 101.99%. These values met with the European regulatory definition of bioequivalence. Reported adverse events were similar in both the test and reference drugs. CONCLUSIONS:This single-dose study found that the test and reference MMF 500 mg tablets met the European regulatory criteria for assuming bioequivalence in fasting, healthy, male subjects. Both formulations were well tolerated. (Clinical Trials Registry - India [CTRI]: 2011/03/002211).
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Patel S,Chauhan V,Mandal J,Shah S,Patel K,Saptarshi D,Maheshwari K,Jha PK,Kale P,Patel K,Mathew Pdoi
10.1016/j.clinthera.2011.04.003subject
Has Abstractpub_date
2011-03-01 00:00:00pages
378-90issue
3eissn
0149-2918issn
1879-114Xpii
S0149-2918(11)00185-8journal_volume
33pub_type
杂志文章,随机对照试验abstract::In this double-masked, double-dummy, randomized, single crossover study, we compared single doses of a fast-dissolving wafer formulation of famotidine with a conventional tablet formulation of ranitidine in patients with gastroesophageal reflux disease (GERD). Patient preference time until symptomatic relief, and pred...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1997-01-01 00:00:00
abstract:PURPOSE:The recommended first-line treatment for young children infected with HIV includes the liquid formulation of the co-formulated protease inhibitors lopinavir/ritonavir (Kaletra® [Abbott Laboratories, Chicago, Illinois]). Clinical reports indicate that some children readily accept the taste of Kaletra, whereas ot...
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abstract:PURPOSE:Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This analysis compared the efficacy and safety of tofacitinib with biologic disease-modifying antirheumatic drugs in patients with RA and a prior inadequate response (IR) to tumor necrosis factor inhibitors (TNFi). ME...
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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 ...
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1983-01-01 00:00:00
abstract::Etodolac, aspirin, and placebo were evaluated for efficacy and safety in 18 patients with adult-onset, active rheumatoid arthritis. This was a 12-week, double-blind, parallel-group study divided into drug titration and maintenance periods and preceded by a washout period of up to two weeks. The mean daily maintenance ...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
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更新日期:1983-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1991-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2009.06.008
更新日期:2009-06-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:
更新日期:1992-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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更新日期:1990-01-01 00:00:00
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doi:10.1016/j.clinthera.2006.09.009
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更新日期:1982-01-01 00:00:00
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pub_type: 杂志文章,评审
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
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更新日期:1985-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2004-07-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
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更新日期:2006-08-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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更新日期:2007-05-01 00:00:00
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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:1985-01-01 00:00:00
abstract:BACKGROUND:Biosimilars are defined as biologic products that are highly similar to reference products, notwithstanding minor differences in clinically inactive components, with no clinically meaningful differences between the biologic product and the reference product in terms of safety profile, purity, and potency. Du...
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pub_type: 杂志文章,评审
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更新日期:2012-02-01 00:00:00
abstract::A 1-year, open-label extension of a 12-week, double-blind clinical trial was conducted to evaluate the long-term safety and efficacy of once-daily therapy with triamcinolone acetonide nasal aerosol (110, 220, or 440 micrograms) in 93 patients with perennial allergic rhinitis. All three doses of triamcinolone acetonide...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1994-03-01 00:00:00
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pub_type: 临床试验,杂志文章,随机对照试验,收录出版
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更新日期:2003-02-01 00:00:00