NCT01372306已完成1 期
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories, Ltd. and Janssen Pharmaceutical Products, l.P. (Reminyl®)4 mg Galantamine HBr Tablets in Healthy Adult Male Volunteers Under Fed 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
- 24
- 主要终点
- Bioequivalence on Cmax and AUC parameters
研究概览
简要总结
Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fed condition.
详细描述
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories, ltd. and Janssen Pharmaceutical Products, l.P. (Reminyl®)4 mg Galantamine HBr Tablets in Healthy Adult Male Volunteers under Fed 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the studyI unless otherwise specified:
- •Healthy adult male volunteers, 18-55 years of age;
- •Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Ufe Insurance Company, 1983);
- •Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs;
- •Give voluntary written informed consent to participate in the study.
排除标准
- •Subject candidates must not be enrolled in the stUdy if they meet any of the following criteria:
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- •In addition, history or presence of:
- •alcoholism or drug abuse within the past year;
- •hypersensitivity or idiosyncratic reaction to galantamine or other anticholinesterase inhibitors;
- •asthma and seizures.
- •Subjects who tested positive at screening for HIV, HbsAg or HCV.
- •Subjects whose PR interval is >200 msec at screening and prior to dosing.
- •Subjects whose QTc interval is >450 msec at screening and prior to dosing.
- •Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
- •Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
- •Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
- •Subjects who, through completion of the stUdy, would have donated in excess of:
- •500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
- •Subjects who have participated in another clinical trial within 28 days prior to the first dose.
研究组 & 干预措施
Galantamine
Experimental
Galantamine Hydrobromide Tablets of Dr. Reddy's
干预措施: Reminyl (Drug)
Reminyl
Active Comparator
Reminyl 4 mg tablets of Janssen Pharmaceutical Products
干预措施: Reminyl (Drug)
结局指标
主要结局
Bioequivalence on Cmax and AUC parameters
时间窗: 2 months
次要结局
未报告次要终点
研究者
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