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implementation of a reference scaled average bioequivalence approach for highly variable acetylsalicylic acid in fixed dose combination with clopidogrel versus enteric aspirin in chinese subjects under fasting conditions a phase 1 open label randomized crossover study

descriptionPublicationkeyboard_double_arrow_right Article , Journal 16 May 2020Publisher:Springer Science and Business Media LLCJournal:Advances in Therapy, volume 37, pages 2,696-2,709 (issn: 0741-238X, eissn: 1865-8652,

Authors: Na Yang; Chuan Ping; Linlin Zhang; Jeffrey E Ming; Lu Wang; Yi Li; Fangyuan Kong; +5 Authors

doi: 10.1007/s12325-020-01369-z

pmid: 32418143

pmc: PMC7467447

implementation of a reference scaled average bioequivalence approach for highly variable acetylsalicylic acid in fixed dose combination with clopidogrel versus enteric aspirin in chinese subjects under fasting conditions a phase 1 open label randomized crossover study

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Abstract

Dual antiplatelet therapy, aspirin and a P2YThis was a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study with a washout period of 10 days conducted in healthy Chinese volunteers. Subjects were randomized to receive Co-PlavixIn total, 171 healthy subjects were enrolled in this study. Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study. Regarding acetylsalicylic acid exposure, as reference within-subject standard deviation (SDApplication of the reference-scaled average bioequivalence approach to evaluate bioequivalence of acetylsalicylic acid in Chinese male and female healthy volunteers under fasting conditions demonstrated bioequivalence of test and reference formulations.CTR20181695.

Related Organizations

N8 Medical (United States)
United States
L3 Médical (France)
France

Keywords

Adult, Male, Cross-Over Studies, Ticlopidine, Aspirin, Thrombosis, Healthy Volunteers, Clopidogrel, Drug Combinations, Asian People, Therapeutic Equivalency, Area Under Curve, Humans, Drug Therapy, Combination, Female, Acute Coronary Syndrome, Original Research

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PRINCIPLES OF STATISTICAL EVALUATION OF BIOEQUIVALENCE STUDIES IN THE CONTEXT OF CURRENT REGULATORY REQUIREMENTS AND LEGAL ACTS
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