CTRI/2012/04/002573已完成未知
An open-label,randomized, single-dose, two-treatment, two-sequence,three-period, replicate crossover study to determine the bioequivalence of SPP100 (aliskiren) 300mg tablets (small tablet vs.marketed formulation) in healthy adult subjects under light meal conditions
ovartis Healthcare Private Limited0 个研究点目标入组 136 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Healthy subjects
- •2. Female subjects must be of non child bearing potential.
- •3. Subjects must weigh at least 50 kg & their BMI 18 to 30 kg/m2 for participation.
排除标准
- •1. Smokers
- •2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- •3.Pregnant or nursing (lactating) women.
- •4.Impaired hepatic or renal function test results.
- •5.A positive Hepatatis B surface antigen (HBsAg)or Hepatatis C test result.
研究者
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