CTRI/2023/07/055363
Not yet recruiting
Phase 4
Assessment of Pharmacokinetic Interaction & Clinical Efficacy of Clopidogrel Coadministered with Ilaprazole
SRM College of Pharmacy SRM Institute of Science and Technology0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SRM College of Pharmacy SRM Institute of Science and Technology
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male volunteers of 18 to 45 years (both years inclusive) and body weight \> 50 kg.
- •Willing to give informed written consent and comply with the study requirements.
- •Subject should be able to communicate effectively.
- •Non\-smokers or individuals who smoke less than 5 cigarettes per day
- •Teetotalers or individuals who drink less than 60 ml of high\-alcohol\-content liquor or 120 ml
- •of low\-alcohol\-content liquor
- •Body Mass Index (BMI) between 18\.50 and 24\.99 Kg/m2
- •Healthy individuals as evaluated by personal history, medical history and general clinical
- •examination.
- •Vital parameters \- BP should be within the range of 100 â?? 139 mmHg systolic and 60 â?? 89
Exclusion Criteria
- •Subjects incapable of understanding the informed consent
- •History of any major surgical procedure in the past 3 months
- •History of diabetes mellitus, tuberculosis and systemic hypertension
- •History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine,
- •neurological, metabolic, psychiatric or hematological systems, judged to be clinically
- •significant.
- •History of dysphagia.
- •History of any medical disorder that is of significance in the investigatorâ??s opinion.
- •Present or past history of drug abuse.
- •History of hypersensitivity to study formulation
Outcomes
Primary Outcomes
Not specified
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