CTRI/2011/06/001849已完成3 期
A bridging study comparing efficacy and safety of novel formulation of artesunate injection in treatment of Plasmodium falciparum malaria - NI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
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. Male and female subjects in the age range of 18-65 years (both inclusive)
- •2. Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition.
- •3. Patients with signs and symptoms of malaria and confirmation of diagnosis by positive blood smear test with asexual forms of Plasmodium falciparum with count equal to or more than 10,000 parasites per ul of blood and requiring parenteral therapy
- •4. Patient must understand and be able, willing, and likely to fully comply with study procedures and restrictions
- •5. Patient willing to come for study follow up as required by study protocol.
排除标准
- •1. Patients with febrile disease other than malaria
- •2. Patients with mixed malarial infections
- •3. Patient with severe malaria
- •4. Patients with abnormal heart function
- •5. Pregnant or lactating women.
- •6. Women of childbearing potential not practicing contraception.
研究者
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