NCT00865241已完成1 期
A Relative Bioavailability Study of 5 mg Glyburide/500 mg Metformin HCl Tablets Under Fasting Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Actavis Inc.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Rate and Extend of Absorption
研究概览
简要总结
The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co. with that of 5 mg/500 mg CLUCOVANCE® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult volunteers under fasting conditions.
详细描述
Study Type: Interventional Study Design: Randomized, single dose, two way crossover study under fasting conditions
Official Title: A Relative Bioavailability Study of 5 mg Glyburide/500 mg Metformin HCl Tablets Under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
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 volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults -1983 Metropolitan Height and Weight Table.
- •Screening Procedures: Each volunteer 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 and hepatitis B surface antigen screens;
- •URINALYSIS: by dipstick, microscopic examination if dipstick positive; and .
- •URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.
- •SERUM PREGNANCY SCREEN (female volunteers only)
- •If female and:
- •of childbearing potential, is practicing an acceptable barrier method of birth control for the duration of the study as judged by the investigator(s), such as condoms, sponge, foams, jellies, diaphragm; intrauterine device (IUD), or abstinence; or
- •is postmenopausal for at least I year; or
- •is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
排除标准
- •Volunteers with a recent history of drug or alcohol addiction or abuse.
- •Volunteers 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 medical investigator).
- •Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- •Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
- •Volunteers demonstrating a positive drug abuse screen when screened for this study.
- •Female volunteers demonstrating a positive pregnancy screen.
- •Female volunteers who are currently breastfeeding.
- •Volunteers with a history of allergic response(s) to glyburide, metformin or related drugs.
- •Volunteers with a history of clinically significant allergies including drug allergies.
- •Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the medical investigator).
- •Volunteers who currently use tobacco products.
- •Volunteers who have taken any drug known to induce or inhibit hepatic• drug metabolism in the 28 days prior to Period I dosing.
- •Volunteers 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.
- •Volunteers 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.
- •Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
- •Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
研究组 & 干预措施
A
Experimental
Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg, single dose
干预措施: Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg (Drug)
B
Active Comparator
CLUCOVANCE® 5 mg/500 mg Tablets, single dose
干预措施: CLUCOVANCE® 5 mg/500 mg Tablets, single dose (Drug)
结局指标
主要结局
Rate and Extend of Absorption
时间窗: 36 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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