CTRI/2023/02/049518
Completed
未知
CLINICAL PHARMACOKINETIC DRUG INTERACTION BETWEEN trans-RESVERATROL AND SIMVASTATIN IN HEALTHY ADULT MALE VOLUNTEERS : A RANDOMISED ,DOUBLE BLIND, PLACEBO CONTROLLED TRIA
SRM COLLEGE OF PHARMACY , SRM INSTITUTE OF SCIENCE AND TECHNOLOGY0 sites20 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SRM COLLEGE OF PHARMACY , SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Willing to give informed written consent and comply with the study requirements.
- •2\.Participants should be able to communicate effectively.
- •3\. Non\-smokers or individuals who smoke less than 5 cigarettes per day.
- •4\. Teetotalers or individuals who drink less than 60 ml of high\-alcohol\-content liquor or 120 ml of low\-alcohol\-content liquor
- •5\.Body Mass Index (BMI) between 18\.50 and 24\.99 Kg/m2
- •6\. Healthy individuals as evaluated by personal history, medical history and general clinical examination.
- •7\. Vital parameters \- BP should be within the range of 100 – 139 mm Hg systolic and 60 – 89 mm Hg diastolic. Pulse rate should be within the range of 60 – 100 / min. Oral temperature between 97\.8° F and 99\.0 ° F. Respiratory rate should be within the range of 14\-18/min.
- •8\. Normal biochemical, hematological and urinary parameters.
- •9\. Normal Chest X\-ray PA view \& ECG in 12 leads.
- •10\. Negative for HIV 1 \& 2, Hepatitis B, Hepatitis C and Syphilis tests.
Exclusion Criteria
- •1\. Participants incapable of understanding the informed consent.
- •2\. History of any major surgical procedure in the past 3 months.
- •3\. History of diabetes mellitus, tuberculosis and systemic hypertension.
- •4\. History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine,
- •neurological,metabolic, psychiatric or hematological systems, judged to be clinically
- •significant.
- •5\. hypersensitivity to study formulation
- •6\. history of drug abuse
- •7\. history of hypersensitivity to study drug and allergic to any vegetables or foods
- •8\. Consumption of grapefruit or its products within 48 hours prior to start of the study
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Clinical Pharmacokinetic drug interaction potential of Maha yogaraja Gugglu Tablet(MYG) Tablet in Adult, Healthy, Human volunteersCTRI/2021/01/030805SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
Completed
Phase 1
Pharmacokinetic drug-drug interaction study between oral 300 mg netupitant/0.50 mg palonosetron fixed dose combination (Akynzeo®) and oral dexamethasone to evaluate the duration of the CYP3A4 inhibition in healthy subjectsInhibitory effect on CYP3A4Not ApplicableISRCTN93845260Helsinn Healthcare SA24
Not yet recruiting
Phase 4
Assesment of Pharmacokinetic drug Interaction and pharmacodynamic response of Clopidogrel Coadministered with IlaprazoleCTRI/2023/07/055363SRM College of Pharmacy SRM Institute of Science and Technology
Completed
Phase 1
Interactions between herbal medicines and the anticoagulant warfariDrug interactions of warfarin with herbal medicines in healthy male subjects. Relevant to Stroke prevention and people receiving warfarinStroke -Other -ACTRN12607000054415Prof Andrew McLachlan60
Completed
Not Applicable
The pharmacokinetic study of drug interaction between metformin and pyrimethamine from microdose to clinical dose in adult healthy volunteershealthy male subjectsJPRN-UMIN000002739Clinical trial Center,Kitasato University East Hospital8