Assesment of Pharmacokinetic drug Interaction and pharmacodynamic response of Clopidogrel Coadministered with Ilaprazole

Phase 4

• Registration Number: CTRI/2023/07/055363
• Lead Sponsor: SRM College of Pharmacy SRM Institute of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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