Bioequivalence Study of Rivastigmine 6 mg Capsules (Single Dose) in Healthy Volunteers

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Abstract

Objective:

To assess the bioequivalence of generic formulation of rivastigmine (test) and Exelon (reference).

Methods:

This randomized, open-label, 2-period, single-dose, 2-treatment, 2-sequence, crossover study was conducted in 40 healthy men under fed condition. Participants were randomized to receive a single dose of Exelon or rivastigmine capsule.

Results:

A total of 31 participants completed the study. Area under the concentration–time curve from time zero to time t (AUC0-t) and area under the concentration–time curve from time zero to infinity (AUC0-∞) for Exelon (mean [standard deviation], h·ng/mL) were 126.40 (56.95) and 129.46 (59.94), respectively, while they were 122.73 (43.46) and 125.08 (45.39) for rivastigmine. Geometric mean ratios of rivastigmine/Exelon were 99.17% for AUC0-t, 98.81% for AUC0-∞, and 105% for maximum observed plasma concentration (Cmax). The 90% confidence intervals (CIs) were 94.14% to 104.46%, 93.77% to 104.12%, and 93.08% to 118.44%, respectively. Both formulations were well tolerated.

Conclusion:

The generic and reference formulations were bioequivalent, as the 90% CIs for Cmax, AUC0-t, and AUC0-∞ were within the range of 80% to 125%.

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