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Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00601666
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : January 23, 2018
Sponsor:
Information provided by:
West-Ward Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Insomnia Drug: Zolpidem Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zolpidem Tartrate Tablets 10 MG Under Fasting Conditions
Study Start Date : March 2004
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Bioequivalence [ Time Frame: Baseline, Two period, Seven day washout ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601666


Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Alan K Copa PRACS Institute, Ltd.

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00601666     History of Changes
Other Study ID Numbers: ZOLP-01
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action