NL-OMON38686已完成不适用
A Phase I, open-label, randomized, 3-way crossover study in 3 Panels of healthy, adult subjects to assess the relative bioavailability of TMC207 following single-dose administration of two pediatric formulations using a 100 mg tablet formulation as the reference, with and without food. - TMC207TBC1002
Janssen Infectious Diseases BVBA0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1)Healthy participant on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG), and the results of blood biochemistry and hematology tests and a urinalysis performed at screening;2)Must have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included ;3)Women must be postmenopausal for at least 2 years.;4) Participants must be non-smokers for at least 3 months prior to screening
排除标准
- •1) Human immunodeficiency virus - type 1 (HIV-1) or type 2 (HIV-2) infection confirmed at screening -Hepatitis A, B or C infection confirmed at screening ;2) A positive urine drug test or alcohol breath test at screening. ;3) History or any currently active disease or condition that the Investigator considers to be clinically significant.;4) Abnormalities in laboratory tests determined at screening.
研究者
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