Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.

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.