Zaleplon 10 mg Capsules Under Non-Fasting Conditions
Condition: Healthy
Intervention: Zaleplon 10 mg Capsules; SONATA® 10 mg capsules
Intervention description: 1 x 10 mg; 1 x 10 mg
Intervention MeSH terms: Zaleplon
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      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.
    

Eligibility criteria:

        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.