alexa Bioequivalence of Glucophage® (Metformin) Tablets from Europe and the United States Tested in Healthy Volunteers
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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Research Article

Bioequivalence of Glucophage® (Metformin) Tablets from Europe and the United States Tested in Healthy Volunteers

Christian Friedrich1, Tobias Brand1, Arne Ring1-3 and Thomas Meinicke1*

1Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany

2University of Leicester, Department of Health Sciences, Leicester, UK

3University of the Free State, Department Mathematical Statistics and Actuarial Science, Bloemfontein, South Africa

*Corresponding Author:
Thomas Meinicke
Therapeutic Area Metabolism
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
Tel: +49 (7351) 54-4700
E-mail: [email protected]

Received Date: July 26, 2013; Accepted Date: March 27, 2014; Published Date: April 04, 2014

Citation: Friedrich C, Brand T, Ring A, Meinicke T (2014) Bioequivalence of Glucophage® (Metformin) Tablets from Europe and the United States Tested in Healthy Volunteers. J Bioequiv Availab 6: 061-066. doi: 10.4172/jbb.1000181

Copyright: © 2014 Friedrich C, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Objectives: To investigate whether Glucophage® (metformin) tablets from Europe are bioequivalent to Glucophage tablets from the United States (US) despite in vitro dissolution differences. Bioequivalence would indicate that global Phase III data collected with either product is valid for the registration of fixed-dose combinations with metformin in both regions. Research design and methods: This study included two parts, both of which were conducted according to a randomised, open-label, single-dose, two-period crossover design. The subjects of Part I (N=28) received the 1000 mg Glucophage products, and the subjects of Part II (N=28) received the 500 mg Glucophage products. Results: At both dose levels (1000 mg and 500 mg), administration of single doses of Glucophage from Europe and the US resulted in comparable exposures, as determined by AUC0-inf and Cmax of metformin. The geometric mean ratios of AUC0-inf and Cmax were close to 100%, and the 90% confidence intervals of AUC0-inf and Cmax were contained within the bioequivalence acceptance limits of 80% to 125%. Incidence of adverse events was low and randomly distributed between treatment groups. Conclusions: Glucophage tablets from Europe and the US were shown to be bioequivalent at doses of 1000 mg and 500 mg. Glucophage tablets from both markets were well tolerated by healthy male and female subjects

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