None listed
Conditions
Interventions
Intervention1: Clopidogrel and Ilaprazole: Ilaprazole 10mg for 8 days
Clopidogrel 75mg for 1 day
Control Intervention1: Clopidogrel and Pantoprazole: Pantoprazole 40 mg for 8 days
Clopidogrel 75mg for
Sponsors
SRM College of Pharmacy SRM Institute of Science and Technology
Eligibility
Inclusion 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 mmHg diastolic. Pulse rate should be within the range of 60 â?? 100 / min. Temperature between 97.8Ë? F and 99.0 Ë? F. Respiratory rate should be within the range of 14-18/min. Normal biochemical, hematological (including coagulation profile) and urinary parameters. ï?· Normal Chest X-ray PA view & ECG in 12 leads. Negative for HIV 1, Hepatitis B, Hepatitis C and Syphilis tests. Negative urine test for drugs of abuse for morphine, barbiturates, benzodiazepines, amphetamine, cocaine (to be performed on the day of check-in). Negative alcohol breath analysis (to be performed on the day of check-in).
Exclusion criteria
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 History of allergy to vegetables and/or food substances and/or any other manifestations suggestive of hypersensitivity reaction Present or past history of intake of drugs which potentially modify kinetics or dynamics of study medication or any other medication judged to be clinically significant by the investigator Consumption of grapefruit / its products within 48 hours prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC, Cmax, Tmax , CL, Vd, t 1â??2Timepoint: Collection of 2ml blood sample just before administration of clopidogrel at 0.5 1 2 3 4 6 12th hour after the administration of the drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse EventsTimepoint: Collection of 2ml blood sample just before administration of clopidogrel at 0.5 1 2 3 4 6 12th hour after the administration of the drug | — |
Countries
India
Contacts
Public ContactDr Vijayakumar TM
SRM College of Pharmacy, SRM Institute of Science and Technology
Outcome results
None listed