None listed
Conditions
Interventions
Intervention1: Hydroxychloroquine: 400mg tablets once daily were given orally with 250 ml of water and antiplatelet activity is noted after 7 days of treatment.
Control Intervention1: aspirin: 75 mg t
Sponsors
PGIMER
Eligibility
Inclusion 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
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 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. Subject consuming NSAIDs or any other drug affecting coagulation, fibrinolysis or platelet function in past 15 days prior to screening. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in clinical or physical determination. Subjects with abnormal laboratory values which are clinically significantly at screening. History of depression, psychosis, schizophrenia or any other severe psychiatric diseases, or epilepsy, or any other illness that may interfere with the aim of the study. History of any chronic disease or suffering from any illness during the study and requiring medication. History of allergy or hypersensitivity to any of the study medication. Tobacco user in any form and refusing to abstain from smoking or consumption of tobacco 72 hours before dosing until last sample collection for study. History of drug dependence or excessive alcohol intake on a habitual basis of more than two units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of the study. History of any other drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ï?¶ Mean fall/mean % fall in the platelet aggregation achieved after 7 days of treatment from the baseline value. Timepoint: After 7 days of treatment with the drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?¶ Mean reduction in the plasma 11-dehydroThromboxane B2 generation from the baseline to the end of 7 days treatment period in the treatment group. ï?¶ Mean change in the plasma fibrinogen level from baseline to the end of 7 days in the treatment group.Timepoint: After 7 days of treatment with the drug. | — |
Countries
India
Contacts
Public ContactDr Samir malhotra
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
Outcome results
None listed