Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT00779051
Brief 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
Study:
NCT00779051
Study Brief:
Protocol Section:
NCT00779051