Arzneimittelforschung 2009; 59(5): 263-268
DOI: 10.1055/s-0031-1296395
Antibiotics · Antimycotics · Antiparasitics · Antiviral Drugs · Chemotherapeutics · Cytostatics
Editio Cantor Verlag Aulendorf (Germany)

Bioequivalence Study of Two Fixed Dose Combination Tablet Formulations of Lopinavir and Ritonavir in Healthy Volunteers

Siddarth Chachad
1   Department of Clinical and Bioequivalence Research, Cipla Ltd., Mumbai, India
,
Amar Lulla
1   Department of Clinical and Bioequivalence Research, Cipla Ltd., Mumbai, India
,
Geena Malhotra
1   Department of Clinical and Bioequivalence Research, Cipla Ltd., Mumbai, India
,
Shrinivas Purandare
1   Department of Clinical and Bioequivalence Research, Cipla Ltd., Mumbai, India
› Author Affiliations
Further Information

Publication History

Publication Date:
13 December 2011 (online)

Abstract

The study was designed to compare the rate and extent of absorption of two fixed dose combination tablet formulations of lopinavir (CAS 192725-17-0) and ritonavir (CAS 155213-67-5). This bioequivalence study was conducted using a standard preparation as reference and a generic alternative as test in 72 adult healthy volunteers within 18–45 years of age who received a single dose of the test or reference product under fasting conditions. A washout period of 10 d was maintained between period I and period II dosing. After dosing, blood samples were collected from 0 h (pre-dose) to 72 h post-dose administration. Lopinavir and ritonavir were quantified using a validated LC-MS/MS method. The data obtained for each subject was evaluated for primary pharmacokinetic variables Cmax, AUC0–72, and AUC0–inf with respect to% ratio and 90% confidence interval for log-transformed data. The 90% confidence intervals (obtained by analysis of variance, ANOVA) were well within the bioequivalence acceptance range of 80% to 125%. Thus, it can be concluded that the evaluated formulations are bioequivalent in terms of rate and extent of absorption. The safety profiles of both the test and reference formulations were comparable.