Bioequivalence study of two generic formulations of 10 mg montelukast tablets in healthy Thai male volunteers.
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.


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 Cmax and AUC0-t, AUCt-inf did not show any significant difference between two formulations and products of montelukast and the 90% confidence intervals of Cmax and AUC0-t, AUCt-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.
Sripalakit
P
P
Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand. pattanas@nu.ac.th
Maphanta
S
S
Saraphanchotiwitthaya
A
A
D000085:Acetates / Q000493:pharmacokinetics*; D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D018592:Cross-Over Studies; D003521:Cyclopropanes; D016568:Drugs, Generic / Q000493:pharmacokinetics*; D006801:Humans; D020024:Leukotriene Antagonists / Q000493:pharmacokinetics*; D008297:Male; D011804:Quinolines / Q000493:pharmacokinetics*; D013440:Sulfides; D013607:Tablets; D013785:Thailand; D013810:Therapeutic Equivalency; D055815:Young Adult
D000085:Acetates; D003521:Cyclopropanes; D016568:Drugs, Generic; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D013607:Tablets; C093875:montelukast