“COMPARATIVE BIOAVAILABILITY AND SAFETY OF SINGLE DOSE BACLOFEN TABLETS, 20 MG OF TEST AND REFERENCE FORMULATION IN HEALTHY ADULT HUMAN SUBJECTS UNDER FASTING CONDITION: AN OPEN LABEL, RANDOMIZED, BALANCED, 2-WAY CROSSOVER STUDY”

Abstract

Objective: The objectives of this study were to compare and evaluate the oral bioavailability of Baclofen Tablets, USP 20 mg (Test Product) of Zydus Lifesciences limited, India with that of Baclofen Tablets, USP 20 mg (Reference Product) of Teva Pharmaceuticals USA, Inc. in healthy, adult, human subjects under fasting conditions and to monitor safety of the subjects.
Methods: This was a randomized, open-label, two-period, two-treatment, two-sequence, crossover, balanced, single dose study with a 7-day washout period. A total twenty-eight healthy adult male human subjects were enrolled and completed the study. All the subjects were dosed orally according to the randomization sequence, after 10 hours of fasting with 240 mL of water at ambient temperature. Serial blood samples were collected at predefined specific interval and was quantified by validated liquid chromatography-tandem mass spectrometry (LCMS/MS) method. The bioavailability was compared using pharmacokinetic parameters
Cmax, Tmax, AUC0-t, and AUC0-∞. Moreover, the 90% confidence interval (CI) for the ratio of logarithmic transformed Cmax, AUC0-t and AUC0-∞ was also used to determine bioequivalence.
Results: The results demonstrate that the pharmacokinetic profile of Baclofen of Test product is comparable to the Reference products. There were no serious adverse events or adverse events reported in the study.
Conclusions: Overall, Baclofen Tablets, USP 20 mg were well tolerated as a single (1 × 20 mg) oral dosage administered under Fasting condition in both test and reference formulation.