Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions

Official Title: “A Relative Bioavailability Study of Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions”

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.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Intervention(s) in this Clinical Trial

• Drug: Zolpidem 10 mg tablets
  • 1 x 10 mg
• Drug: AMBIEN® 10 mg tablets
  • 1 x 10 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Zolpidem
  • Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
• Active Comparator: Ambien®
  • Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period

Primary Measures

• Cmax - Maximum Observed Concentration
  • Time Frame: Blood samples collected over 24 hour period
    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
    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
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Teva Pharmaceuticals USA Industry

Overall Clinical Trial Officials and Contacts

Shirley Ann Kennedy, M.D. Principal Investigator Novum Pharmaceuticals Research Services  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00833937

Study ID Number: B016540

ClinicalTrials.gov Identifier: NCT00833937

Health Authority: United States: Institutional Review Board