Clopidogrel 75 mg tablet
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Clopidogrel 75 mg Tablet: Bioequivalence and Pharmacokinetics
Bioequivalence of Clopidogrel 75 mg Tablets
Bioequivalence Studies in Healthy Volunteers
Several studies have evaluated the bioequivalence of clopidogrel 75 mg tablets, comparing generic formulations to the branded Plavix. These studies typically involve healthy volunteers under both fasting and fed conditions. The primary pharmacokinetic parameters assessed include the maximum observed concentration (Cmax) and the area under the concentration-time curve (AUC).
A study conducted with 64 healthy subjects under fasting conditions demonstrated that the test and reference formulations of clopidogrel were bioequivalent, with 90% confidence intervals (CIs) for both Cmax and AUC falling within the acceptable range of 80-125%. Similarly, another study in healthy Argentinian volunteers confirmed bioequivalence between a generic clopidogrel formulation and Plavix, with geometric mean ratios for Cmax and AUC also within the 80-125% range.
Comparative Studies Under Fed Conditions
Bioequivalence under fed conditions has also been explored. A study involving healthy Chinese subjects compared a fixed-dose combination of clopidogrel and aspirin with the coadministration of individual formulations. The results indicated that the fixed-dose combination was bioequivalent to the individual formulations, with 90% CIs for Cmax and AUC within the 80-125% range. Another study in Chinese volunteers under both fed and fasted conditions confirmed bioequivalence between two clopidogrel formulations, with pharmacokinetic parameters meeting the regulatory criteria.
Pharmacokinetics and Pharmacodynamics
Pharmacokinetic Parameters
The pharmacokinetic profile of clopidogrel involves rapid absorption and conversion to its active metabolite. Studies have shown that the pharmacokinetic parameters, such as Cmax and AUC, are consistent across different formulations, ensuring similar therapeutic effects. For instance, a study comparing two clopidogrel formulations in Mediterranean volunteers found no significant differences in pharmacokinetic parameters, with point estimates for Cmax and AUC within the bioequivalence limits.
Pharmacodynamic Effects
Clopidogrel's antiplatelet effect is a critical aspect of its therapeutic efficacy. A study assessing the pharmacodynamic response in healthy subjects demonstrated that a loading dose of clopidogrel followed by a daily maintenance dose achieved a steady-state level of platelet inhibition within hours. Another study comparing the antiplatelet effects of 75 mg and 150 mg daily doses in patients with ST-segment elevation myocardial infarction (STEMI) found that the higher dose significantly reduced platelet aggregation and inflammation.
Conclusion
The bioequivalence of clopidogrel 75 mg tablets has been well-established across multiple studies, ensuring that generic formulations provide the same therapeutic benefits as the branded Plavix. Both pharmacokinetic and pharmacodynamic parameters support the efficacy and safety of these formulations, making clopidogrel a reliable option for antiplatelet therapy in various clinical settings.
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