Assessment of Pharmacokinetic Interaction & Clinical Efficacy of Clopidogrel Coadministered with Ilaprazole

SRM College of Pharmacy SRM Institute of Science and Technology0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

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•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).

•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.

发起方

SRM College of Pharmacy SRM Institute of Science and Technology