Zaleplon 10mg Capsules Under Fasting Conditions
Condition: Healthy
Intervention: Zaleplon 10 mg Capsules; Sonata® 10 mg Capsules
Intervention description: 1 x 10 mg, single-dose fasting; 1 x 10 mg, single-dose fasting
Intervention MeSH terms: Zaleplon
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      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.
    

Eligibility 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.