ISRCTN22508774已完成未知
A single dose two-phase crossover study to assess the tolerability and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets in healthy normal volunteers (Thailand)
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)0 个研究点目标入组 0 人开始时间: 2006年2月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 性别
- All
入选标准
- •1. Age 18 to 50 years
- •2. Written consent given after reading the volunteer information leaflet. Participation must be voluntary and volunteers will be fully informed of possible side effects. They will be informed that they are free to withdraw at any time
- •3. No significant abnormal findings on history or examination, particularly no prior liver disease, cardiovascular disease (including arrythmias), peripheral neuropathy, convulsions, and psychiatric disease
- •4. No clinically significant abnormalities on:
- •4.1. Haematology:
- •4.1.1. Haemoglobin: male 13.6 - 17.5 g/dl, female 12 - 15.5 g/dl
- •4.1.2. Total white cell count: 4 - 10 x 10^3/ul
- •4.1.3. Platelet counts: 150 - 450 x 10^3/ul
- •4.2. Liver:
- •4.2.1. Total bilirubin less than 1.2 mg/dl
- •4.2.2. Serum Glutamic Oxaloacetic Transaminase (SGOT) less than or equal to 35 IU/l
- •4.2.3. Serum Glutamic Pyruvic Transaminase (SGPT) less than or equal to 35 IU/l
- •4.3. Renal function:
- •4.3.1. Creatinine 50 - 100 umol/l
- •4.3.2. Blood urea nitrogen 8 - 20 mg/dl
- •5. Negative pregnancy test (women) using the urine beta Human Chorionic Gonadotropin (ßHCG)
- •6. Normal electrocardiogram (physicians reading: running at 50 mm/sec)
- •7. No history of antimalarial ingestion (chloroquine, amodiaquine, quinine, halofantrine, pyrimethamine-sulfadoxine) in the preceding two months, and for mefloquine, preceding three months
- •8. No other drugs or medications, including over-the counter preparations, ingested in the preceding week
- •9. Adequate venous access
- •10. Not participating in another clinical trial
排除标准
- •1. Refusal of consent
- •2. Clinically significant physical signs detected by the examining physician
- •3. Abnormal electrocardiogram detected by the examining physician
- •4. Presence of hepatic, renal and gastrointestinal disorders
- •5. Smokers (greater than 10 cigarettes/day), abuse of alcohol or recreational drugs
- •6. Presence of malaria parasites on a thick smear
- •7. Subjects having been in a malarial area in the preceding eight weeks
- •8. Subjects having ingested drugs in the preceding week
- •9. Presence of acute or chronic infections
- •10. Allergy to study drugs
研究者
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