CTRI/2015/01/005417已完成1 期
An Open-Label, Two-Period, Single Sequence, Cross-Over, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Dose Erythromycin on the Pharmacokinetics of GRC 17536 After a Single Dose in Healthy Male Subjects.
Glenmark Pharmaceuticals SA0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- •1. Normal healthy male volunteers of >=18 to <= 45 years of age.
- •2. Healthy as determined by medical history, physical examination, chest X-ray, 12-lead ECG and laboratory investigations.
- •3. Able and willing to abstain from methylxanthine-containing beverages or food.
- •4. Non-smokers or ex-smokers for at least 12 months with history of less than a 10-pack per year.
排除标准
- •1. Have abnormal and clinically significant results on the physical examination, medical history, chest X-ray, 12-lead ECG and lab investigations.
- •2. Volunteers with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •3. History of alcohol abuse or drug addiction as seen on positive screen on drugs of abuse or positive alcohol breath test.
- •4. Positive screen on hepatitis-B surface antigen (HBsAg), antibodies to the Hepatitis C virus (anti-HCV) or antibodies to the human immunodeficiency virus (HIV) 1/2; or rapid plasma reagin or VDRL.
- •5. Subjects with known history of liver disease or any abnormal liver function tests at screening.
- •6. Current diagnosis of active epilepsy or any active seizure disorder requiring therapy with antiepileptic drug(s.
- •7. History of hypersensitivity to erythromycin or other macrolide compound; or past history of hepatic impairment, hepatitis or cholestatic hepatitis.
研究者
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