NCT01133496已完成1 期
Open Label, Balanced, Randomized, Two-way, Single-dose, Crossover Bioequivalence Study of Alendronate Sodium 70 mg Tablets of Dr Reddy's, India and Fosamax® Tablets of Merck & Co., Inc., USA, in Healthy Subjects 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
- 入组人数
- 80
- 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 bioequivalence of Alendronate Sodium 70 mg of Dr. Reddy's and Fosamax Tablets 70 mg of Merck & Co.
详细描述
Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study of Alendronate sodium 70 mg tablets of Dr Reddy's Laboratories Limited, India and Fosamax® tablets of Merck & Co., Inc., USA, in healthy, adult, human subjects under 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
- •Healthy human subjects aged between 18 and 45 years (including both).
- •Subjects with a BMI between 18.5 - 24.9 Kg/m2 but weight not less than 45 Kgs.
- •Female subjects who are postmenopausal or surgically sterile.
- •Female subjects 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.
- •Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations and serology tests.
- •Subjects having normal 12-lead electrocardiogram (ECG).
- •Subjects having normal chest X-Ray (P/A view).
- •Subjects able to communicate effectively.
- •Subjects willing to given written informed consent and adhere to all the requirements of this protocol.
排除标准
- •Subjects having contraindications or hypersensitivity to Alendronate sodium or related drugs.
- •History or presence of any medical condition or disease according the opinion of the physician.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •History or presence of significant alcoholism or drug abuse in the past one year.
- •History or presence of significant smoking (more than 10 cigarettes or beedi's/day or consumption of tobacco products).
- •Difficulty with donating blood.
- •Difficulty in swallowing solids like tablets or capsules.
- •Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
- •Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- •Pulse rate less than 50/minute or more than 100/minute.
- •Use of any prescribed medication during last two weeks or OTC medical products during the last one week preceding the first dosing.
- •Major illness during 3 months before screening.
- •Participation in a drug research study within past 3 months.
- •Donation of blood in the past 3 months before screening.
- •Female volunteers demonstrating a positive pregnancy screen.
- •Female volunteers who are currently breast-feeding.
- •Female volunteers with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).
研究组 & 干预措施
Alendronate Sodium
Experimental
Alendronate Sodium Tablets, 70 mg of Dr. Reddy's
干预措施: Alendronate Sodium Tablets, 70 mg (Drug)
Fosamax
Active Comparator
Fosamax Tablets 70 mg of Merck & Company. Inc., USA.
干预措施: Alendronate Sodium Tablets, 70 mg (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC parameters
时间窗: 5 months
次要结局
未报告次要终点
研究者
研究点 (1)
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