Zaleplon 10mg Capsules Under Fasting Conditions - Full Text View

Purpose

The objective of this study was to compare the relative bioavailability of Zaleplon 10 mg Capsules manufactured by TEVA Pharmaceuticals USA and Sonata® 10 mg Capsules manufactured by Wyeth Laboratories in healthy, non-smoking adults under fasting conditions.

Condition	Intervention	Phase
Healthy	Drug: Zaleplon 10 mg Capsules Drug: Sonata® 10 mg Capsules	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 Zaleplon 10mg Capsules Under Fasting Conditions

Resource links provided by NLM:

Drug Information available for: Zaleplon

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 10 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 10 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 10 hour period ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	February 2004
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Zaleplon Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period	Drug: Zaleplon 10 mg Capsules 1 x 10 mg, single-dose fasting
Active Comparator: Sonata® Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period	Drug: Sonata® 10 mg Capsules 1 x 10 mg, single-dose fasting

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:

non-smokers
at least 18 years of age
BMI of 30 or less

Exclusion Criteria:

Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
Subjects whose clinical laboratory test values are outside the reference ranges may be retested at the discretion of the clinical investigator. 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 with intolerance to alcohol or other CNS depressants should not participate in this 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. Female subjects who have used hormonal oral contraceptives within 14 days of dosing or implanted or injected hormonal contraceptives within 180 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: NCT00829998

Locations

United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77040

Sponsors and Collaborators

Teva Pharmaceuticals USA

Investigators

Principal Investigator:

So Ran Hong, M.D.

Novum Pharmaceutical Research Services

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00829998 History of Changes
Other Study ID Numbers:	BO46501
Study First Received:	January 26, 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:

Zaleplon
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants

ClinicalTrials.gov processed this record on June 17, 2013