alexa Bioequivalence Study of Two Loperamide Hydrochloride 2 mg Formulations: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Study in Healthy Volunteers under Fasting Conditions
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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Research Article

Bioequivalence Study of Two Loperamide Hydrochloride 2 mg Formulations: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Study in Healthy Volunteers under Fasting Conditions

Wen Yao Mak1#*, Yi Lin Lee1#, Siew Siew Tan2, Jia Woei Wong2, Siaw Kuen Chin2, Ai Boey Lim2, Ean Peng Soon2, Irene Looi1 and Kah Hay Yuen2

1Clinical Research Centre, Hospital Seberang Jaya, Jalan Tun Hussein Onn, 13700 Seberang Jaya, Pulau Pinang, Malaysia

2Attest Research Sdn Bhd, BA/BE Laboratory, Room 024, Kompleks EUREKA, Universiti Sains Malaysia, 11800 USM, Pulau Pinang, Malaysia

#Co-authors

*Corresponding Author:
Wen Yao Mak
Clinical Research Centre
Hospital Seberang Jaya
Jalan Tun Hussein Onn
13700 Seberang Jaya, Pulau Pinang, Malaysia
Tel: 04-3827333 Ext 511
Fax: 04-3902192
E-mail: [email protected]

Received Date: March 21, 2016 Accepted Date: April 21, 2016 Published Date: April 28, 2016

Citation: Mak WY, Lee YL, Tan SS, Wong JW, Chin SK, et al. (2016) Bioequivalence Study of Two Loperamide Hydrochloride 2 mg Formulations: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Study in Healthy Volunteers under Fasting Conditions. J Bioequiv Availab 8:145-148. doi:10.4172/jbb.1000285

Copyright: © 2016 Mak WY, 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

The objective of this study was to compare the rate and extent of drug absorption of the test product (Colodium 2 mg Capsule, Hovid Bhd.) against the reference product (Imodium® 2 mg Capsule, Janssen Cilag S.A.) in twentythree healthy male volunteers under fasting condition in order to evaluate bioequivalence. A single dose of 8 mg (4 capsules of 2 mg each) of test and reference products were given to volunteers during two periods of the study respectively. There was a 7 day washout period between the two study periods. Blood samples were taken at pre-dose and at 13 time points up till 48 h post dosing. Plasma levels of loperamide were determined by liquid chromatography-tandem mass spectrometry. The plasma concentration-time data was used to estimate the pharmacokinetic parameters, namely, Cmax, Tmax, AUC0-t and AUC0-∞. Analysis of variance (ANOVA) procedure was used to analyze the values of Cmax, AUC0-t, AUC0-∞ and ke obtained from the two preparations. For the analysis of Tmax values, the Wilcoxon Signed Rank Test for paired samples was used. In this study, the 90% confidence interval for the ratio of the AUC0-t, AUC0-∞ and Cmax were calculated to be between 0.8730-1.0181, 0.8852-0.9891 and 0.8023- 0.9559 respectively. All of the values were within the acceptable bioequivalence requirement of 0.8000-1.2500. No drug-related adverse event was reported throughout the study. Thus, the two preparations could be concluded to be bioequivalent and interchangeable.

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