Bioequivalence Study of Clopivas (Cipla brand of Clopidogrel) vs Plavix (International brand of Clopidogrel)

19 Apr, 14

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Aim

To assess the bioequivalence & tolerability of Cipla's clopidogrel, Clopivas, vs the international brand of clopidogrel i.e. Plavix

Study Groups

Test formulation - Clopivas
Reference formulation - Plavix

All patients received 300 mg loading dose (4 of 75 mg tablets of respective formulations) of clopidogrel on day 1, followed by 1 tablet of 75 mg clopidogrel (respective formulations) at 8:00 am daily for next 6 days

Bioequivalence Assessment Parameters

Percent of platelet aggregation
Inhibition of platelet aggregation
- Mean of maximum activity of percentage of inhibition of platelet aggregation (E_max)
- Mean time to reach E_max (t_max)
- Mean area under the activity-time curve from time 0-168 hrs (AUC_0-168)
Bleeding time (difference was considered as significant if a difference of >1.5-fold was found between the 2 formulations)

All parameters were assessed before the first dose & at 2 hrs, 5 hrs, 12 hrs, 24 hrs (prior to dosing), 48 hrs (prior to dosing), 72 hrs (prior to dosing), 120 hrs (prior to dosing) & 168 hrs after study drug administration

Tolerability Assessment Parameters

Blood pressure & heart rate measurements before & every hour for first 12 hrs & then at 24 hrs after drug administration
Platelet count on days 3, 6, 10 after first-dose administration
Neutrophil count on day 10 after first-dose administration

Results

Mean percentages of inhibition were similar between the two formulations both at 2 hrs (34% with Clopivas & 28% with Plavix) & maintained till the end of 168 hrs (37% with Clopivas vs 32% with Plavix)

E_max, t_max & AUC_0-168 were similar in both the clopidogrel formulations

Bleeding time was comparable in both the clopidogrel formulations throughout the study period

Safety

There was no serious side-effect reported with either formulations & no participant discontinued due to adverse event
The only adverse effect reported was mild & transient headache which was experienced by a participant receiving Plavix
Platelet & neutrophil count were within the normal limits

Conclusion

Clopivas was bioequivalent to the innovator brand Plavix & was well tolerated in the study population

Curr Ther Res Clin Exp 2003;64:685-96

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Aim

Study Participants