CTRI/2013/03/003485
Completed
Phase 4
A study on Hydroxychloroquine efficacy as an antiplatelet agent in healthy volunteers:comparison with aspirin and clopidogrel - HEAT study
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- PGIMER
- Enrollment
- 20
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Normal healthy male volunteers.
- •Body weight of 55kg and above.
- •Willing to give written, informed consent.
- •Subjects with full comprehension and ability to understand the purpose and the nature of trial
- •Agreeing to refrain from smoking and alcohol during the trial period.
- •Willing to comply with protocol requirement as evidenced by informed consent documents.
- •Subjects with normal findings as determined by baseline history, Physical examination and vital signs.
- •No abnormality detected on X\-ray chest \& ECG.
- •No history or presence of significant alcoholism or drug abuse in the past one year.
Exclusion Criteria
- •History of having donated blood in the past 3 months.
- •History of participating in any IND study in last 6 months.
- •History of participating in any non\-IND study in the past 3 months.
- •Have been treated with any known enzyme inducing or inhibiting drugs within 30 days of the study.
- •History or presence of gastrointestinal disorders likely to influence drug absorption including actual GI symptoms (e.g. nausea, vomiting, diarrhoea, heart burn), preceding one week to admission.
- •Subjects with known history of /active HIV I or II, Hepatitis B or C viruses or HBsAg positivity or syphilis infection.
- •Subjects with disease of blood or haematopoietic organs (haemoglobin \< 11 g/dl).
- •Subjects with abnormal renal function, (Serum Cr \>1\.5 mg/dl).
- •Subjects with abnormal liver function (AST and ALT, total Bilirubin, Creatinine phosphokinase or alkaline phosphatase \> 2\.5 times the upper limit of normal values) or active liver disease.
- •History of taking non\-allopathic drug in the past 6 months for any illness.
Investigators
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