Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting Conditions
Condition: Healthy
Intervention: Alprazolam Extended-Release 3 mg Tablets; Alprazolam Extended-Release 3 mg Tablets
Intervention description: 1 x 3 mg, single dose non-fasting; 1 x 3 mg, single dose non-fasting
Intervention MeSH terms: Alprazolam
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg
      Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA
      with that of 3 mg XANAX XR® Tablets by Pharmacia & Upjohn Company following a single oral
      dose (1 x 3 mg extended release tablet) in healthy adult subjects administered under
      non-fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Screening Demographics: All subjects selected for this study will be healthy
             non-smoking men and women 18 years of age or older at the time of dosing. The
             subject's body mass index (BMI) should be less than or equal to 30.

          -  Screening procedures: Each subject 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.

          -  Screening will include general observations, physical examination, demographics,
             medical and medication history, an electrocardiogram, sitting blood pressure and heart
             rate, respiratory rate and temperature. The physical examination will include, but may
             not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory,
             and central nervous systems.

        The screening clinical laboratory procedures will include:

          -  Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet
             count;

          -  Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total
             bilirubin, total protein, and alkaline phosphatase;

          -  HIV antibody, hepatitis B surface antigen, hepatitis C antibody screens;

          -  Urinalysis: by dipstick; full microscopic examination if dipstick positive; and

          -  Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines,
             cannabinoids, cocaine metabolites, opiates, and phencyclidine.

          -  Serum Pregnancy Screen (female subjects only)

          -  FSH (to verify postmenopausal status; female subjects only)

        If female and:

          -  is postmenopausal for at least 1 year and has a serum FSH level ≥ 20mIU/mL; or

          -  is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
             hysterectomy).

        Exclusion Criteria:

          -  Subjects with a recent history of dug or alcohol addiction or abuse.

          -  Subjects with the presence of a clinically significant disorder involving the
             cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
             endocrine, or neurologic system(s) or psychiatric disease (as determined by the
             clinical investigators).

          -  Subjects whose clinical laboratory test values are outside the accepted reference
             range and when confirmed on re-examination are deemed to be clinically significant.

          -  Subjects demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C
             antibody or HIV antibody.

          -  Subjects demonstrating positive drug abuse screen when screened for this study.

          -  Female subjects demonstrating a positive pregnancy screen.

          -  Female subjects who are currently breast-feeding.

          -  Subjects with a history of allergic response(s) to alprazolam or related drugs.

          -  Subjects with a history of clinically significant allergies including drug allergies.

          -  Subjects with a clinically significant illness during the 4 weeks prior to Period I
             dosing (as determined by the clinical investigators).

          -  Subjects who currently use or report using tobacco products within 90 days of Period I
             dose administration.

          -  Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in
             the 28 days prior to Period I dosing.

          -  Subjects 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 plasma for four weeks
             after completing the study.

          -  Subjects who report receiving any investigational drug within 28 days prior to Period
             I dosing.

          -  Subjects who report taking any systemic prescription medication in the 14 days prior
             to Period I dosing.

          -  Subjects who report an intolerance of direct venipuncture.

          -  Subjects who report consuming an abnormal diet during the 28 days prior to Period I
             dosing.