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Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00833937
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : August 18, 2009
Last Update Posted : August 18, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The objective of this study is to compare the relative bioavailability of Zolpidem tartrate 10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle & Co.) in healthy, adult, non-smoking subjects under non-fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Zolpidem 10 mg tablets Drug: AMBIEN® 10 mg tablets Phase 1

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Relative Bioavailability Study of Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions
Study Start Date : March 2002
Primary Completion Date : March 2002
Study Completion Date : March 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Zolpidem
Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
Drug: Zolpidem 10 mg tablets
1 x 10 mg
Active Comparator: Ambien®
Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
Drug: AMBIEN® 10 mg tablets
1 x 10 mg


Outcome Measures

Primary Outcome Measures :
  1. Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 24 hour period ]
  2. AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 24 hour period ]
  3. AUC0-t - Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 24 hour period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less.

Exclusion Criteria:

  • Subjects with a significant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
  • Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
  • All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
  • Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
  • Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  • Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
  • All Female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
  • Subjects who do not tolerate venipuncture will not be allowed to participate.
Contacts and Locations

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): NCT00833937


Locations
United States, Pennsylvania
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, United States, 15206
United States, Texas
Bioassay Laboratory, Inc.
Houston, Texas, United States, 77099
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Shirley Ann Kennedy, M.D. Novum Pharmaceuticals Research Services
More Information

ClinicalTrials.gov Identifier: NCT00833937     History of Changes
Other Study ID Numbers: B016540
First Posted: February 2, 2009    Key Record Dates
Results First Posted: August 18, 2009
Last Update Posted: August 18, 2009
Last Verified: July 2009

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

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