Zeitschrift für Bioäquivalenz und Bioverfügbarkeit

Abstrakt

A Bioequivalence Study of Two Finofibrate Tablet Formulations in Indian Healthy Subjects

Nilesh Wagh, Gayakwad NJ, Christina AJM, Amit Bhople and Anup Thakre

Aim: To compare the bioavailability of two Finofibrate 145 mg tablet as test formulation and 145 mg tablet as reference formulation.

Method: Randomized, single dose, open-label, three-treatment, three-period, three-sequence, crossover design under fasting period with 9 days wash out period was evaluated in 18 subjects.

For the analysis of pharmacokinetic properties, the blood samples were drawn taken up to 72 hours after dosing. Plasma concentration of Finofibrate was determined using High performance liquid chromatography (HPLC) – mass spectrometry method. Pharmacokinetic parameters AUC0-t, AUC0-∞ and Cmax were tested for bioequivalence after log-transformation of data and ratios of tmax were evaluated.

Result: The point estimates and 90% confidence intervals (CI) A vs. C for Cmax, AUC0-t and AUC0-∞, for Finofibrate were 62.84%, 85.03%, 86.34% respectively. The point estimates and 90% confidence intervals (CI) B vs. C for Cmax, AUC0-t and AUC0-∞, for Finofibrate were 82.89%, 95.87% and 96.63% respectively.

Conclusion: Based on clinical, pharmacokinetic and statistical data obtained from 18 healthy adult male human subjects under fasting conditions, it may be concluded that a single dose of test formulation of drug ‘Finofibrate’ 145 mg tablet manufactured by Wockhardt Limited, India does not meet bioequivalence criteria of 80.00% to 125% for Cmax, AUCo-t and AUC0-∞ when compared with reference formulation 145 mg Finofibrate® ‘Tablet.