Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fasted Conditions
Status:
Completed
Trial end date:
2005-07-01
Target enrollment:
Participant gender:
Summary
- Objective:
- To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test
Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited,
India Reference Product: Ambien® Tablets 10 mg (Reference Listed Drug) manufactured
by Sanofi- Synthelabo Inc. under fasting conditions in 24 healthy, adult, human
subjects.
- Study Design:
- Open label, randomized, two-period, two-treatment, two-sequence single dose
crossover design.