CTRI/2010/091/001323尚未招募未知
An open label, randomized, 2 x 3 crossover study to evaluatebioequivalence between fixed-dose combination of SAH100 tablets (300/5/25mg aliskiren/amlodipine/HCTZ) and free combination of market formulation of 300mg aliskiren tablet, and clinical service formulations of 5mg amlodipine and 25mg hydrochlorothiazide in healthy subjects under light meal conditions
ovartis Healthcare Pvt. Ltd. Raheja IT Park, Mind Space - Bld # 6, Hitech City,Village - Madhapur,Hyderabad 500081, India0 个研究点目标入组 124 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Healthy male and female subjects, aged 18 to 55 years (inclusive) and in good health as determined by past medical history, physical examination, vital signs assessments, electrocardiogram, and laboratory tests at screening. -
- •Non-smokers.
- •-Body mass index (BMI) must be 18 ? 30 kg/m2 (inclusive) and subjects must weigh at least 50 kg.
排除标准
- •-Female subjects of child bearing potential.
- •-Lactating and breast feeding females.
- •-Hemoglobin levels below 12.0 g/dl.
- •-A past and current medical history of clinically significant ECG abnormalities.
- •-A known hypersensitivity or other intolerance to the study drugs or drugs similar to the study drug.
- •-Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs or which may jeopardize the subject in case of participation in the study.
- •-A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •-History of head and neck angioedema.
- •-History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
研究者
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