Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions

Insomnia Clinical Trial

Official title:

A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zolpidem Tartrate Tablets 10 MG Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601666
• Other study ID #: ZOLP-01
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: January 19, 2018
• Start date: March 2004
• Est. completion date: March 2004

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• Zolpidem

Locations

Country	Name	City	State
United States	PRACS Institute, Ltd.	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence		Baseline, Two period, Seven day washout