Bioequivalence Evaluation of Gliclazide 80 Mg in Healthy Volunteers

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  • Topic: Pharmacokinetics, Bioequivalence, Generic drug
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Student Name: Purav TRIVEDI Thesis Title: Bioequivalence evaluation of two formulations of Gliclazide 80 mg in healthy human volunteers Cranfiled Health Master of Science Thesis _____________________________________________________

CRANFIELD UNIVERSITY

Cranfiled Health M Sc THESIS
Academic Year 2005-2007 Purav TRIVEDI “Bioequivalence evaluation of two formulations of Gliclazide 80 mg in healthy human volunteers” Student Reference Number: s-093568

Supervisor:

Dr S Gajabhiye

Institute of Clinical Research (India) Mumbai May 2009
This thesis is submitted in partial fulfilment of the requirements for the degree of Master of Science

S093568 © Cranfield University 2009. All rights reserved. No part of this publication may be reproduced without the written permission of the copyright owner

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ABSTRACT: Aim: The study aimed to assess and compare the bioavailability and bioequivalence of two formulations of Gliclazide 80 mg in 14 healthy male volunteers along with the safety profile. Methods: Subject were selected and enrolled in study after successful screening and assessment of health status. After an overnight fasting, Gliclazide tablets, test and reference, were orally administered to 14 volunteers as per randomization schedule with 200 ml of 20% glucose solution and 50 ml of drinking water in each of two periods. Total of 16 blood samples were collected, and the concentration determined for Gliclazide up to 72 hours after the administration. Gliclazide was measured using HPLC. The standard statistical analysis was carried out after the Bioanalytical results obtained. Results: The mean age of 14 volunteers was 26.79, mean BMI was 20.87 and clinical laboratory parameters were within normal limits. The Bioanalytical results show that the Test formulation exhibited mean peak plasma concentration (Cmax) at 4.39±1.1 µg/ml, the time to reach Cmax (Tmax) was 4.21 ±1.1 hr. The AUC0-t and AUC0-∞ had mean values of 65.91±41.4 µg.hr/ml and 1.77±59.5 µg.hr/ml, respectively. The corresponding Cmax, Tmax, AUC0-t and AUC0-∞ values for the Reference formulation were 4.29 ±1.26 µg/ml, 4.71±1.1 hr, 64.53±34.37 µg.hr/ml and 78.38±38.78 µg.hr/ml respectively. ANOVA was carried out using logarithmic transformations of Cmax, AUC0-t and AUC0-∞ and the mean (90% CI) of the Cmax, AUC0-t and AUC0-∞ ratios (test/reference) were 1.04 (0.94-1.13); 0.99 (0.87-1.12) and 1.06 (0.90-1.23) respectively. Conclusions: The results showed that the 90% confidence interval was within the acceptable limit of 0.8-1.25. Based on the statistical results the test formulation of Gliclazide is recommended to be considered as bioequivalent to the reference formulation. Both formulations were equally tolerated and safe.

S093568 © Cranfield University 2009. All rights reserved. No part of this publication may be reproduced without the written permission of the copyright owner

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ACKNOWLEDGEMENT:

The author acknowledged the help and guidance provided by the seniors and colleagues at BV Patel PERD Centre, Ahmedabad. This work is a result of a clinical study which was collaborative team effort put forth by various departments at this centre and other support staff.

In particular, sincere thanks to Dr Shah, Dr Kapadia and Dr Padh, Director of the centre, for their help and guidance, Dr V Kumar from the sponsor company for the permission of producing this work; and Dr. Gajabhiye, Supervisor and principal ICRI, Mumbai, for her inputs in drafting this work.

S093568 © Cranfield University 2009. All rights reserved. No part of this publication may be reproduced without the written permission of the copyright owner

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