Key result
Generic clopidogrel meets bioequivalence criteria compared to branded Plavix.
Why the study?
The study was performed to compare the bioavailability of two clopidogrel 75 mg tablet formulations in healthy volunteers.
Does the Sandoz formulation of clopidogrel 75 mg provide equivalent bioavailability to Plavix in healthy volunteers?
RCT (n=42)
Open-label
Randomized
No
Does the Sandoz formulation of clopidogrel 75 mg provide equivalent bioavailability to Plavix in healthy volunteers?
Effect estimate: Ratio 100.33% (95% CI 95.50-105.40)
Absolute Event Rate: 14466.86% vs 14433.14%
A generic formulation of clopidogrel 75 mg (Sandoz) demonstrated bioequivalence to the reference product (Plavix) in healthy volunteers.
Sandoz clopidogrel meets bioequivalence criteria in healthy volunteers; leaves open interchangeability in patients with variable CYP2C19 activity.
The study was performed to compare the bioavailability of two clopidogrel 75 mg tablet formulation (Clopidogrel from Sandoz as test formulation and Plavix from Sanofi-Synthelabo Ltda, Brazil, as reference formulation) in 42 volunteers of both sexes.The study was conducted open with randomized two period crossover design and a one week wash out period.Plasma samples were obtained over a 48 hour interval.The carboxylic acid of Clopidogrel, major metabolite of Clopidogrel, was analyzed by LC-MS-MS, in the presence of enalapril maleate as internal standard.With plasma concentration vs. time curves, data obtained from this metabolite, the following pharmacokinetics parameters were obtained: AUC 0-t , AUC 0-inf and C max .Geometric mean of Clopidogrel/Plavix 75 mg individual percent ratio was 100.33%AUC 0-t , 98.96% for AUC 0-inf and 105.83% for C max .The 90% confidence intervals were 95.50-105.40%,94.45-103.69%,95.91-116.78%,respectively.Since the 90% confidence intervals for C max , AUC 0-t and AUC 0-inf were within the 80-125% interval proposed by Food and Drug Administration, it was concluded that Clopidogrel 75 mg Tablet was bioequivalent to Plavix 75 mg tablet according to both the rate and extent of absorption.
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Abib et al. (2010) conducted an RCT in Healthy volunteers (n=42). Clopidogrel (Sandoz formulation) vs. Clopidogrel (Plavix formulation) was evaluated on Bioequivalence based on AUC0-t of clopidogrel carboxylic acid (Ratio 100.33%, 95% CI 95.50-105.40). The Sandoz formulation of clopidogrel 75 mg was bioequivalent to the Plavix reference formulation, with the 90% confidence intervals for Cmax, AUC0-t, and AUC0-inf all falling within the 80-125% acceptance range.
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