90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions
Condition: Healthy
Intervention: Fluoxetine Hydrochloride; PROZAC WEEKLY®
Intervention description: 90 mg Capsules; 90 mg Capsules
Intervention MeSH terms: Fluoxetine
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      This study compared the relative bioavailability (rate and extent of absorption) of 90 mg
      Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC
      WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy
      adult volunteers under non-fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Screening Demographics: All volunteers selected for this study will be healthy men or
             women 18 years or age or older at the time of dosing. The weight range will not exceed
             + 15% for height and body frame as per Desirable Weights for Men - 1983 Metropolitan
             Height and Weight Table or as per Desirable Weights for Women - 1983 Metropolitan
             Height and Weight Table.

          -  Screening Procedures: Each volunteer will complete the screening process within 28
             days prior to Period I dosing. Consent documents for both the screening evaluation and
             HIV antibody determination will be reviewed, discussed, and signed by each potential
             participant before full implementation of screening procedures.

          -  If female and:

               -  Of childbearing potential, is practicing an acceptable method of birth control
                  for the duration of the study as judged by the investigator(s), or

               -  Is postmenopausal for at least 1 year, or

               -  Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
                  hysterectomy).

        Exclusion Criteria:

          -  Volunteers with a recent history of drug or alcohol addiction or abuse.

          -  Volunteers with the presence of a clinically significant disorder involving the
             cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
             endocrine, or neurological system(s) or psychiatric disease (as determined by the
             clinical investigators).

          -  Volunteers whose clinical laboratory test values are outside the acceptable reference
             range and when confirmed on re-examination are deemed to be clinically significant.

          -  Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive
             HIV antibody screen.

          -  Volunteers demonstrating a positive drug abuse screen when screened for this study.

          -  Female volunteers demonstrating a positive pregnancy screen.

          -  Female volunteers who are currently breastfeeding.

          -  Volunteers with a history of allergic response(s) to fluoxetine or related drugs.

          -  Volunteers with a history of clinically significant allergies including drug
             allergies.

          -  Volunteers with a clinically significant illness during the 4 weeks prior to Period I
             dosing (as determined by the clinical investigators).

          -  Volunteers who currently use tobacco products.

          -  Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism
             in the 30 days prior to Period I dosing.

          -  Volunteers who report donating greater than 150 mL of blood within 30 days prior to
             Period I dosing. All subjects will be advised not to donate blood for 4 weeks after
             completing the study.

          -  Volunteers who have donated plasma within 14 days prior to Period I dosing. All
             subjects will be advised not to donate plasma for 4 weeks after completing the study.

          -  Volunteers who report receiving any investigational drug within 30 days prior to
             Period I dosing.

          -  Volunteers who report taking any systemic prescription medications in the 14 days
             prior to Period I dosing.