Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under 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 fasting; 1 x 3 mg, single dose fasting
Intervention MeSH terms: Alprazolam
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
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 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.