Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions - Full Text View

Purpose

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 fasting conditions.

Condition	Intervention	Phase
Healthy	Drug: Zolpidem 10 mg tablets Drug: AMBIEN® 10 mg tablets	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	A Relative BioAvailability Study of Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions

Resource links provided by NLM:

Drug Information available for: Zolpidem Zolpidem tartrate

U.S. FDA Resources

Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:

Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 24 hour period ] [ Designated as safety issue: No ]
AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 24 hour period ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	38
Study Start Date:	February 2002
Study Completion Date:	February 2002
Primary Completion Date:	February 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833521

Locations

United States, Pennsylvania
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, United States, 15206

Sponsors and Collaborators

Teva Pharmaceuticals USA

Investigators

Principal Investigator:

Shirley Ann Kennedy, M.D.

Novum Pharmaceutical Research Services

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00833521 History of Changes
Other Study ID Numbers:	B016539
Study First Received:	January 30, 2009
Results First Received:	July 6, 2009
Last Updated:	July 6, 2009
Health Authority:	United States: Institutional Review Board

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
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 May 22, 2013