生物学的同等性とバイオアベイラビリティのジャーナル

概要

A Bioequivalence Comparison of Two Captopril Formulations (25 mg Tablets): An Open-Label, Randomized, Two-Treatment, Two-Way Crossover Study in Healthy Volunteers

Chik Z, Deril NM, Didi EMH, Basu RC, Ratnasingam J and Mohamed Z

This was an open-label, randomized, 2-treatment, 2-way crossover study with 1 week washout period between the 2 study arms. Healthy volunteers received a 25 mg tablet of the test formulation or 25 mg tablet of the reference formulation. Plasma concentrations of captopril were analyzed using a validated LC-MS/MS method. The mean values for Cmax, Tmax, AUC0–t, and AUC0–∞ with the test formulation of captopril were 235.21 ng/mL, 0.82 hours, 329.25 ng/mL•h, and 337.43 ng/mL•h, respectively; for the reference formulation, the values were 228.28 ng/mL, 0.72 h, 315.87 ng/mL•h, and 323.90 ng/mL•h. For captopril, the 90% CIs for the test formulation/reference formulation ratio for both log Cmax and AUC0–∞ were within the bioequivalence limit of 80% to 125% (81.08–122.78% and 85.19– 117.68%). Both formulations appeared well tolerated in the population studied.