An Open Label, Balanced, Randomized, Two Treatment, Three Sequence, Three Period, Single Dose, Cross Over, Semi-Replicate, Oral Bioequivalence Pivotal Study Of Tenofovir 245 Mg Film Coated Tablets and Tenofovir(Viread)245 Mg Film Coated Tablets In Healthy, Adult, Human, Male Subjects Under Fed Conditions.

AIM AND OBJECTIVES: To compare the bioavailability of tenofovir film coated tablets with the conventional dosage form given in equivalent doses. To estimate the serum concentration of film coated tablet oftenofovir (test) and conventional tenofovir (reference) through bio-analytical method validation using LC-MS/MS. To monitor the adverse events and ensure safety of the subjects. METHODS: The study was conducted at Azidus Laboratories Ltd., located at Rathnamangalam, vandalur, Chennai-48 in collaboration with Institute of Pharmacology, Madras Medical College Chennai. Study Design: An open label, balanced, randomized, two treatment, three sequence, three period, single dose, cross over, Semi-replicate, oral bioequivalence pivotal studyunder fed conditions. Study Type:Prospective Bioequivalence study.DISCUSSION Bioequivalence studies are fundamentally satisfied through single dose administration. The focus is on the rate and extent of absorption of the active ingredient. They are conducted in healthy normal subjects under fasting or fed conditions. Most comparative bioavailability studies are conducted to identify the quantitative with intravenous dose, modified release with conventional preparation and for a generic product, test and reference. Nowadays, bioequivalence studies are a pivotal part of registration dossiers. These studies measure the bioavailability of two or more formulations of the same active ingredient. The purpose of the study is to show the bioavailability of the formulations under investigation is equal. Based on the conclusion that the therapeutic qualities of these formulations are identical, these formulations can be interchangeable. In this study, Test and Reference product containing Tenofovir 245 mg were evaluated for the safety upon single dose administration to normal healthy adult male subjects under fed conditions. There was a washout period of 7 days between the three periods. The overall duration of the study was 19 days including the wash out period. Blood samples were collected at the predetermined time points to elicit the pharmacokinetic profiles of Tenofovir. Vital parameters measured at the scheduled time intervals were normal and within the acceptable range of all study subjects. This study was conducted with Tenofovir 245 mg (test) and Tenofovir245 mg(reference) to establish the drugs concentration versus time profile and the results of the pharmacokinetic analysis of Tenofovir of the test(T) product were compared with the reference(R) product. Analysis of variance for Ln-transformed pharmacokinetic parameters revealed that there was no significant variation between test and reference formulation for these three primary pharmacokinetic parameters Cmax and AUC0-t, &AUC0-∞.CONCLUSION: From this study, we can conclude that the therapeutic quality of the formulation, test and reference Tenofovir 245 are identical. The test Tenofovir is bioequivalent to reference Tenofovir. Both the test and reference products have comparable safety profile