NCT00779051

Bioequivalence Study of Zolpidem 10mg Tablets Under Fasting Conditions

An Open Label, Relative Bioavailability Study of 10 mg Zolpidem Tablet Under 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 fasting condition

Detailed description

This was a single-center, randomized, open label, two-way cross over study conducted under 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. Subject 07 elected to withdraw foe personal reasons prior to period II check in. Subject 22 was excluded from statistical analysis due to emesis before twice the median Tmax of reference product

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zolpidem 10mg tablets

Timeline

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

Locations

1 site across 1 country: United States