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Journal of Bioequivalence & Bioavailability
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Research Article

Pharmacokinetics of a Novel Orodispersible Tablet of Amlodipine in Healthy Subjects

Vincent Mascoli1*, Uma Kuruganti2, Akula Thukaram Bapuji3, Rong Wang2 and Bharat Damle1

1Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

2Pfizer Inc., 445 Eastern Point Road, Groton, CT 06340, USA

3Aurobindo Pharma Ltd., Plot # 2, Maitri Vihar, Ameerpet, Hyderabad 500 038, Andhra Pradesh, India

*Corresponding Author:
Vincent Mascoli
Pfizer Inc., 235 East 42nd Street
New York 10017, USA
Tel: 212-573-1358
E-mail: [email protected]

Received Date: December 14, 2012; Accepted Date: January 16, 2013; Published Date: January 22, 2013

Citation: Mascoli V, Kuruganti U, Bapuji AT, Wang R, Damle B (2013) Pharmacokinetics of a Novel Orodispersible Tablet of Amlodipine in Healthy Subjects. J Bioequiv Availab 5:076-079. doi: 10.4172/jbb.1000138

Copyright: © 2013 Mascoli V, 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

Purpose: An orally disintegrating tablet (ODT) of amlodipine has been developed for the benefit of patients who have difficulty swallowing solid dosage forms. Methods: Two pivotal bioequivalence studies of amlodipine ODT given with and without water, versus either amlodipine tablets or capsules, were conducted in 36 subjects each. Both studies were randomized, open-label, crossover, single-dose (10 mg) studies in healthy subjects ages 18 to 55 years. Plasma samples were collected for 168 hours post dose and pharmacokinetics were determined by non-compartmental analyses. Results: Amlodipine ODT with or without water was bioequivalent to amlodipine tablets as the ratio (90% CI) of Cmax, AUC∞, and AUClast were contained within 80–125%. Amlodipine ODT with or without water was also bioequivalent to amlodipine capsules as the ratio (90% CI) of Cmax, AUC∞, and AUClast were contained within 80–125%. Conclusion: Amlodipine ODT, given with or without water, provides equivalent systemic exposure compared to amlodipine tablets or capsules.

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