NCT01132027已完成1 期
An Open Label, Two Way Crossover, Balanced, Single Dose, Comparative Evaluation of Relative Bioavailability of Tacrolimus Capsules 5 mg With That of 'Prograf' Capsules 5 mg in Healthy Subjects Under Non-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
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bioavailability study based on Cmax and AUC parameters
研究概览
简要总结
The purpose of this study is to compare the relative bioavailability study of tacrolimus capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under non-fasting conditions and to monitor safety of subjects.
详细描述
An open label, randomized, two period, two treatment, two sequence, crossover, balanced, single dose, comparative evaluation of relative bioavailability of tacrolimus capsules 5 mg with that of 'prograf' capsules 5 mg in healthy adult human subjects under non-fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •The subjects should be healthy human between 18 and 45 years.
- •The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
- •The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.
- •The subjects should be able to communicate effectively with study personnel.
- •The subjects should be able to give written informed consent to participate in the study.
- •If subject is a female volunteer and
- •Is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms,foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- •Is postmenopausal for at least 1 year.
- •Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
排除标准
- •The subjects who have a history of allergic responses to tacrolimus or other related drugs.
- •The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG, and X-ray recordings.
- •The subjects who have any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- •The subjects who have a history or presence of bronchial asthma.
- •The subjects who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
- •The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses.
- •The subjects who are smokers who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period.
- •The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
- •The subjects who have donated 1 unit (350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
- •The subjects who have a positive hepatitis screen (include subtypes A, B, C and E).
- •The subjects who have a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
- •The subject who receives an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication application.
- •Female volunteers demonstrating a positive pregnancy screen.
- •Female volunteers who are currently breast-feeding.
- •Female volunteers not willing to use contraception during the study.
研究组 & 干预措施
Tacrolimus
Experimental
Tacrolimus Capsules, 5 mg of Dr.Reddy's Laboratories Limited
干预措施: Tacrolimus Capsules (Drug)
Prograf Capsules
Active Comparator
Prograf Capsules of Astellas Pharma US, Inc.,
干预措施: Tacrolimus Capsules (Drug)
结局指标
主要结局
Bioavailability study based on Cmax and AUC parameters
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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