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Nilesh Wagh
Nilesh Wagh
University Department of Pharmaceutical Sciences,
Maharashtra
India
Publications
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Research Article
A Bioequivalence Study of Two Finofibrate Tablet Formulations in Indian Healthy Subjects
Author(s): Nilesh Wagh, Gayakwad NJ, Christina AJM, Amit Bhople and Anup ThakreNilesh 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-.. View More»
DOI: 10.4172/jbb.1000129