Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions
Status:
Completed
Trial end date:
2015-09-21
Target enrollment:
Participant gender:
Summary
This study is conducted to determine whether the test product (GW483100 10 mg containing
montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference
montelukast sodium 10 mg tablets (innovator product) in healthy adult volunteers under
fasting conditions. This is an open-label, balanced, randomized, single dose, two-way
crossover study, enrolling 32 healthy human subjects to ensure at least 28 subjects complete
the study. Each subject enrolled will participate in two treatment periods separated by a
washout period of at least 7 days and no more than 14 days between dosing occasions. Total
duration in the study for each subject will be approximately 7 weeks from screening to the
subject's last visit.