A Relative Bioavailability Study of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets Under Fasting Conditions.

Teva Pharmaceuticals USA2 个研究点分布在 1 个国家目标入组 40 人开始时间: 2004年6月最近更新: 2009年9月15日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Teva Pharmaceuticals USA
入组人数: 40
试验地点: 2
主要终点: AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]- Glipizide

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult subjects administered under fasting conditions.

详细描述

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

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 45 Years（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 men and women 18-45 years of age, inclusive, 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, and 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
•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), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), or abstinence; or
•is postmenopausal for at least 1 year; or
•is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

排除标准

•Subjects with a recent history of drug 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 hepatitis B surface antigen screen, a reactive hepatitis C antibody screen, or a reactive HIV antibody screen.
•Subjects demonstrating a positive drug abuse screen when screened for this study.
•Female subjects demonstrating a positive pregnancy screen.
•Female subjects who are currently breastfeeding.
•Subjects with a history of allergic response(s) to glipizide, metformin hydrochloride, 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 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
•Subjects who have donated plasma (e.g. plasmapheresis) within 14 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

Glipizide Metformin

Experimental

Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period

干预措施: 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets (Drug)

Metaglip®

Active Comparator

Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period

干预措施: 5 mg/500 mg METAGLIP™ Tablets (Drug)

结局指标

主要结局

AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]- Glipizide