A Relative Bioavailability Study of 3 mg Alprazolam Extended Release Tablets Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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).
排除标准
- •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.
研究组 & 干预措施
Alprazolam
Alprazolam 3mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
干预措施: Alprazolam Extended-Release 3 mg Tablets (Drug)
Xanax XR®
Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg ER Tablet (test) dosed in second period
干预措施: Alprazolam Extended-Release 3 mg Tablets (Drug)
结局指标
主要结局
Cmax - Maximum Observed Concentration
时间窗: Blood samples collected over 72 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
时间窗: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
时间窗: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-t
次要结局
未报告次要终点