Abstract

Objective: to compare the bioavailabilities of two generic brands of montelukast available in the Thailand (Montek^® and Tomont^®) with the original brand (Singulair^®) in healthy Thai male volunteers under fasting condition. Materials and methods: A randomized, single-dose, two-period, two-sequence, crossover study design with a 1-week wash-out period was done in 24 healthy Thai male volunteers for each study. Blood samples for plasma montelukast levels were collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16 and 24 h after administration, and was then analyzed using a validated HPLC method. The pharmacokinetic parameters were determined from plasma concentration-time profile of test and reference products by using non-compartment analysis. Results: In each study, the ANOVA of C_max and AUC_0-t, AUC_t–inf did not show any significant difference between two formulations and products of montelukast and the 90% confidence intervals of C_max and AUC_0-t, AUC_t–inf fell within the acceptable range of Thailand Food and Drug Administration. Conclusions: It can be concluded that Montek^® and Tomont^® are bioequivalent to Singulair^®, and that two generic products can be considered interchangeable with the reference in medical practice.

Author Details

Authors

• P. Sripalakit
• S. Maphanta
• A. Saraphanchotiwitthaya

Departments

• Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand

Address

P. Sripalakit, PhD
Bioequivalence Test Center
Faculty of Pharmaceutical Sciences
Naresuan University
Phitsanulok 65000, Thailand
Email: [email protected]

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