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Zaleplon 10 mg Capsules Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00829868
First received: January 26, 2009
Last updated: July 6, 2009
Last verified: July 2009

January 26, 2009
July 6, 2009
February 2004
March 2004   (final data collection date for primary outcome measure)
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 12 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 12 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 12 hour period ] [ Designated as safety issue: No ]
Bioequivalence based on Cmax and AUC [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00829868 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Zaleplon 10 mg Capsules Under Non-Fasting Conditions
A Relative Bioavailability Study of Zaleplon 10 mg Capsules Under Non-Fasting Conditions

The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, adult subjects under non-fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Zaleplon 10 mg Capsules
    1 x 10 mg
  • Drug: SONATA® 10 mg capsules
    1 x 10 mg
  • Experimental: Zaleplon
    Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
    Intervention: Drug: Zaleplon 10 mg Capsules
  • Active Comparator: Sonata®
    Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
    Intervention: Drug: SONATA® 10 mg capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
March 2004
March 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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(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 range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range of 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 history of allergic responses to the class of drug being tested will be excluded from the study. Subjects with intolerance to alcohol or or other CNS depressants should not participate in this study.
  • Subjects whou 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 whi 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) of 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 of inconclusive results will be withdrawn from the study.
  • Subjects who do not tolerate venipuncture will not be allowed to participate.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829868
B046502
No
Not Provided
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: So Ran Hong, M.D. Novum Pharmaceuticals Research Services
Teva Pharmaceuticals USA
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP