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Background: The present study was conducted to investigate the bioequivalence of Ritonavir Capsules 100 mg with that of Norvir Ritonavir Capsules Soft Gelatin 100 mg. Patients and methods: This study was an open-label, balanced, randomized, two-treatment, twoperiod, two-sequence, single dose crossover pilot oral bioequivalence study. Study was conducted in 12 healthy, adult male subjects with age ranging from 18 to 45 years. The total duration (excluding screening) of subject participation in a study was approximately 11 days including washout period of 07 days between each dosing. The estimation of Ritonavir in human plasma is carried out by using LC/MS/MS method in Bioanalytical laboratory. The pharmacokinetic parameters assessed were AUC0-t, AUC0-∞, Cmax, AUC0-t/AUC0-∞, Tmax, kel and t1⁄2. Results: The geometric mean ratios (90% confidence intervals) of the test drug/reference drug for Ritonavir were 100.8 (83.64-121.51) for AUC0-t, 102.1 (85.39-122.01) for AUC0-inf, and 97.5 (81.19117.08) for Cmax. The 90% confidence intervals of the test/reference AUC0-t, AUC0-∞, Cmax ratio of Ritonavir were within the acceptance range for bioequivalence. In this study, single dose of Ritonavir 100 mg capsule was well tolerated by both groups of subjects under fasting conditions. Conclusion: It was concluded that the two Ritonavir capsules formulations (the test and reference products) were bioequivalent in terms of the rate and extent of absorption. Introduction Situations in which bioequivalence studies are required:  When significant changes are made in the manufacture of the marketed formulation, and  When a new generic formulation is tested against the innovator’s marketed product. Bioequivalent simply means that one brand or dosage form of a drug or supplement is equivalent to a reference brand or dosage form of the same drug or supplement in terms of various bioavailability parameters measured via in vivo testing in human subjects. The purpose of the study to compare and evaluate the single-dose oral bioavailability of Ritonavir Capsules 100 mg with NORVIR Ritonavir Capsules Soft Gelatin 100 mg of Abbott Laboratories, USA in healthy, adult, male, human subjects under fasting conditions. General regulatory considerations for BA/BE studies The processes of study design and workflow of BA/BE studies are presented in brief in below. The general considerations for the advancement of conducting BA/BE studies are: • Study design and protocol. • Bio analysis. • Selection of appropriate analysts. • BE metrics and data treatment. • Statistical approaches and analysis.

texila international journal of clinical research

An Open-Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single-dose Crossover Pilot Oral Bioequivalence Study of Ritonavir Capsules 100 mg with NORVIR® Ritonavir Capsules Soft Gelatin 100 mg of Abbott Laboratories, USA in Healthy, Adult, Male, Human Subjects Under Fasting Conditions