Key result
A single 75 mg oral dose of the test clopidogrel preparation was bioequivalent to the reference drug, demonstrating a relative bioavailability of 101.7 ± 35.3%.
Why the study?
Is a test preparation of 75 mg clopidogrel bioequivalent to the reference preparation in healthy Chinese volunteers?
RCT (n=32)
Open-label
crossover
Is a test preparation of 75 mg clopidogrel bioequivalent to the reference preparation in healthy Chinese volunteers?
Effect estimate: Relative bioavailability 101.7 ± 35.3%
A test preparation of 75 mg clopidogrel was shown to be bioequivalent to the reference preparation in healthy Chinese volunteers.
Supports interchangeability of the test clopidogrel preparation; confirms bioequivalence in Chinese volunteers.
We aimed to evaluate the bioequivalence of clopidogrel in healthy Chinese volunteers after administration of a single oral dose. We administered a single oral dose of 75 mg clopidogrel (test and reference) to 32 healthy Chinese volunteers according to an open, randomized, crossover design. The concentration of clopidogrel acid (carboxylic metabolite of clopidogrel) in the plasma was determined using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Bioequivalence of the test and reference preparations were calculated using analysis of variance and one-sided t-test by using the DAS 2.0 software. The pharmacokinetic parameters of the test and reference preparations were as follows: peak plasma concentration (Cmax), 1351.101 ± 654.955 ng/mL and 1184.652 ± 607.713 ng/mL; area under the curve, 2642.017 ± 1093.848 ng·h/mL and 2780.666 ± 1283.100 ng·h/mL; and time to reach Cmax (Tmax), 0.789 ± 0.318 h and 0.953 ± 0.633 h, respectively. The relative bioavailability of the formulation was 101.7 ± 35.3%, which indicated that the test preparation was bioequivalent to the reference drug.
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Yang et al. (2015) conducted an RCT in Healthy (n=32). Clopidogrel hydrogen sulfate (test) vs. Clopidogrel (reference) was evaluated on Relative bioavailability (Relative bioavailability 101.7 ± 35.3%). A single 75 mg oral dose of the test clopidogrel preparation was bioequivalent to the reference drug, demonstrating a relative bioavailability of 101.7 ± 35.3%.
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