NCT01131936已完成1 期
An Open-Label Randomized Single-Dose Bioequivalence Study of Amlodipine 10 mg Tablets and Norvasc ® 10 mg Tablets 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
- 试验地点
- 1
- 主要终点
- Bioequivalence based on Cmax and AUC parameters
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fed conditions.
详细描述
This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Tablets 10 mg of Dr. Reddy's versus Norvasc 10 mg tablets administered as 1 x 10 mg tablet in healthy volunteers with a washout period of 14 days.
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
- •Healthy subjects between 18 and 45 years of age inclusive.
- •Informed of the nature of the study and given written informed consent.
- •Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weigh at least 115 (Appendix I and Appendix II).
排除标准
- •If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the three treatment periods. Females must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of themselves or their partners or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
- •Hypersensitivity to amlodipine besylate (Norvasc®)or related calcium channel blockers).
- •Any history of a clinical condition that might affect drug absorption, metabolism or excretion.
- •Recent history of mental illness, drug addiction, drug abuse or alcoholism.
- •Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- •Received an investigational drug within the 4 weeks prior to study dosing.
- •Currently taking any prescription medication, except for oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or -herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
- •Regular tobacco use in the 6 months prior to study dosing.
研究组 & 干预措施
Amlodipine Tablets, 10 mg
Experimental
Amlodipine Tablets, 10 mg of Dr. Reddy's Laboratories Limited
干预措施: Amlodipine (Drug)
Norvasc Tablets, 10 mg
Active Comparator
干预措施: Amlodipine (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC parameters
时间窗: 4 months
次要结局
未报告次要终点
研究者
研究点 (1)
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