CTRI/2010/091/001353已完成1 期
Phase 1 human study for single dose combination of oral Alpha-ketoglutarate (5 grams and 15 grams) & Inj. Sodium Thiosulphate 12.5 grams i.v.
Defence R&D Organisation0 个研究点目标入组 26 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
- 26
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. Healthy human volunteers 18 - 50 years of age with 50-70kg of body weight.
- •2. On no permanent treatment
- •3. Suffering from no permanent / recurrent / chronic disease or disability
- •1. Otherwise healthy human volunteers of 25 - 60 years of age with 50-70kg of body weight, half with history of mild to moderate essential hypertension (systolic blood pressure between 140-160 mm Hg at time of test), with or without treatment.
排除标准
- •1. Volunteers who do not sign the consent form.
- •2. Those with any contraindication for giving AKG/STS/SNP and those who are hypotensive
- •3. Patients with abnormalities in the laboratory screen (SGOP or SGPT > 1.5 times upper limit of normal, alkaline phosphates > 1.2 times upper limit of normal, serum creatinine> 1.5 mg/dl)
- •4. Patients who have any medical condition which in the judgment the investigator may render them inappropriate for participation in the trial
- •5. Patients who have received any other investigational drug for the last 1 month
- •6. Patients with smoking history of >10 pack-years
研究者
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