Key result
A fixed-dose combination of clopidogrel and aspirin was bioequivalent to coadministration of individual formulations, with a clopidogrel Cmax geometric mean ratio of 1.08 (90% CI 0.95-1.23).
Why the study?
Does a fixed-dose combination of clopidogrel and aspirin provide bioequivalent pharmacokinetics compared to coadministration of individual formulations in healthy Korean men?
RCT (n=60)
open-label
randomized
Does a fixed-dose combination of clopidogrel and aspirin provide bioequivalent pharmacokinetics compared to coadministration of individual formulations in healthy Korean men?
Effect estimate: GMR 1.08 (for clopidogrel Cmax) (95% CI 0.95-1.23)
A fixed-dose combination of clopidogrel and aspirin is bioequivalent to the coadministration of individual formulations, supporting its use to improve patient compliance.
Supports fixed-dose clopidogrel-aspirin prescribing to improve adherence; confirms bioequivalence in healthy Korean men.
Background: Simultaneous prescription of clopidogrel and low-dose aspirin is recommended for the treatment of acute coronary syndrome because of improvements in efficacy and patient compliance. In this study, the pharmacokinetics of a fixed-dose combination (FDC) of clopidogrel and aspirin was compared with coadministration of individual formulations to clarify the equivalence of the FDC. Methods: This was a randomized, open-label, two-period, two-treatment, crossover study in healthy Korean men aged 20–55 years. Subjects received two FDC capsules of clopidogrel/aspirin 75/100 mg (test) or two tablets of clopidogrel 75 mg and two capsules of aspirin 100 mg (reference) with a 14-day washout period. Plasma concentrations of clopidogrel, aspirin, and salicylic acid were measured using validated ultraperformance liquid chromatography–tandem mass spectrometry. Bioequivalence was assessed by analysis of variance and calculation of the 90% confidence intervals (CIs) of the ratios of the geometric means (GMRs) for AUC last and C max for clopidogrel and aspirin. Results: Sixty healthy subjects were enrolled, and 53 completed the study. Clopidogrel, aspirin, and salicylic acid showed similar absorption profiles and no significant differences in C max , AUC last , and T max between FDC administration and coadministration of individual formulations. The GMRs (90% CI) for the C max and AUC last of clopidogrel were 1.08 (0.95, 1.23) and 0.93 (0.84, 1.03), respectively. The GMRs (90% CI) for the C max and AUC last of aspirin were 0.98 (0.84, 1.13) and 0.98 (0.93, 1.04), respectively. Both treatments were well tolerated in the study subjects. Conclusion: The FDC of clopidogrel and aspirin was bioequivalent to coadministration of each individual formulation. The FDC capsule exhibited similar safety and tolerability profiles to the individual formulations. Therefore, clopidogrel/aspirin 75 mg/100 mg FDC capsules can be prescribed to improve patient compliance.
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Choi et al. (2016) conducted an RCT in Healthy (n=60). Fixed-dose combination of clopidogrel and aspirin vs. Coadministration of individual formulations (clopidogrel 75 mg and aspirin 100 mg) was evaluated on Bioequivalence assessed by AUC last and C max for clopidogrel and aspirin (GMR 1.08 (for clopidogrel Cmax), 95% CI 0.95-1.23). A fixed-dose combination of clopidogrel and aspirin was bioequivalent to coadministration of individual formulations, with a clopidogrel Cmax geometric mean ratio of 1.08 (90% CI 0.95-1.23).
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