Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions

Not Applicable

Completed

• Conditions: Insomnia

• Registration Number: NCT00601666
• Lead Sponsor: Roxane Laboratories

Brief Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria

• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with known enzyme altering drugs.
• History of allergic or adverse response to Zolpidem or any comparable or similar product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence	Baseline, Two period, Seven day washout

Trial Locations

Locations (1)

PRACS Institute, Ltd.; 🇺🇸 Fargo, North Dakota, United States