NCT00779441

Bioequivalence Study of Zolpidem 10 mg Tablets Under Fed Conditions

An Open Label, Relative Bioavailability Study of 10 mg Zolpidem Tablet Under Non-Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study compared the relative bioavailability (rate and extent of absorption) of 10 mg Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg Ambien® tablets distributed by Sanofi-Synthelabo, Inc. following single oral dose (1x10 mg tablet) in healthy adult volunteers administered under non-fasting conditions

Detailed description

This was a single-center, randomized, open label, two-way cross over study conducted under non-fasting conditions. Subjects checked into the clinical facility the day prior to dosing at least 10 hours prior to dose administration. On study day 1, subjects were dosed with single oral dose (1x10mg tablet) of the test and reference products thirty minutes after initiation of a standardized, high fat breakfast which was preceded by an overnight fast. Following a seven day wash out period, subjects returned and were dosed with an alternative treatment as per randomization Thirty-six (N=36) volunteers were enrolled in the study of which 17 were females and 19 were males. Subject 22 was dropped from further study participation prior to period II check in due to adverse events

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zolpidem 10mg tablets

Timeline

• Start date: 2005-08-01
• Primary completion: 2005-09-01
• Completion: 2005-11-01
• First posted: 2008-10-24
• Last updated: 2008-10-24

Locations

1 site across 1 country: United States