R.T.M. Nagpur University, India
N.J.Gaikwad has awarded Ph.D. in 1988 from Nagpur University and working as Professor in Department of Pharmaceutical Sciences, RTM Nagpur University. He has teaching and research experience of 34 years. He supervised 4 All India Council for Technical Education major project as a Principal Investigator, published 30 research papers in reputed journals and also published 4 books in Pharmacy. He guided 21 Doctoral and 44 Post-graduate students, chief Coordinator in International Conference on Brain Research organized by International Brain Research Organization, Switzerland. He act Board of Governer in National Education and research, Govt. of India, Director in Hindustan Organic Chemical Limited, Mumbai, Zim Lab.Ltd.,Kalmeshwar, Unijules Nagpur.He is associated with various professional and Social organization.
Aim: To compare the bioavailability of two Finofi brate 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 taken up to 72 hours aft er dosing. Plasma concentration of Finofi brate was determined using High Performance Liquid Chromatography (HPLC) - Mass Spectrometry method. Pharmacokinetic parameters AUC0-t, AUC0-∞ and Cmax were tested for bioequivalence aft er log-transformation of data and ratios of tmax were evaluated. Result: Th e point estimates and 90% confi dence intervals (CI) Avs. C for Cmax, AUC0-t and AUC0-∞, for Finofi brate were 62.84%, 85.03%, 86.34% respectively. Th e point estimates and 90% confi dence intervals (CI) Bvs. C for Cmax, AUC0-t and AUC0-∞, for Finofi brate 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 ‘Finofi brate’ 145 mg tablet manufactured by Wockhardt Limited, India does not meet bioequivalence criteria of 80% to 125% for Cmax, AUCo-t and AUC0-∞ when compared with reference formulation 145 mg Finofi brate®‘Tablet.