Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00601666
First received: January 15, 2008
Last updated: February 5, 2008
Last verified: February 2008
  Purpose

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 Intervention
Insomnia
Drug: Zolpidem

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: Baseline, Two period, Seven day washout ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2004
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

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
Study First Received: January 15, 2008
Last Updated: February 5, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014