A Bioequivalence Comparison of Two Captopril Formulations (25 mg Tablets): An Open-Label, Randomized, Two-Treatment, Two-Way Crossover Study in Healthy Volunteers
- *Corresponding Author:
- Deril NM
University of Malaya Bioequivalence and Testing Centre (UBAT)
Department of Pharmacology, Faculty of Medicine
University of Malaya, Kuala Lumpur, Malaysia
E-mail: [email protected]
Received Date: March 12, 2014; Accepted Date: April 28, 2014; Published Date: May 04, 2014
Citation: Chik Z, Deril NM, Didi EMH, Basu RC, Ratnasingam J, et al. (2014) A Bioequivalence Comparison of Two Captopril Formulations (25 mg Tablets): An Open-Label, Randomized, Two-Treatment, Two-Way Crossover Study in Healthy Volunteers. J Bioequiv Availab 6: 080-085. doi: 10.4172/jbb.10000185
Copyright: © 2014 Chik Z, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.