RBR-105nyj86已完成1 期
Bioavailability study of two formulations of Primaquine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 50Y（—）
入选标准
- •Non-pregnant and non-breastfeeding women
- •Within the age range 18 to 50 years old
- •Body Mass index range 19 to 28,5 Kg/m2
- •Health volunteers
- •Signed Informed Consent
排除标准
- •Hypersensibility to the drug (primaquine): Previous pathologies that could influence the absorption distribution or excretion of the drug; Positive G6PD deficiency quantitative or pregnancy test. Use o concomitant medicines; Any clinical or laboratory exam abnormality;
- •Smokers; heavy coffee drinkers (>5 cups/Day); Abusive alcohol use: use of any treatment within 2 weeks before the study;Any previous hospitalization with 8 weeks before the study: Any previous treatment with known drug interaction with the test drug within 03 months; Blood donation greater than 450ml 03 months prior the study, or 1500ml in the previous 12 months; Use of Cyp 450 Inductors medications 4 weeks prior; Consume of alcohol or grapefruit 48h prior hospitalization;
研究者
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