CTRI/2010/091/001353
Completed
Phase 1
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 sites26 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Defence R&D Organisation
- Enrollment
- 26
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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