None listed
Conditions
Interventions
Intervention1: trans-RESVERATROL: trans-RESVERATROL CAPSULE 500mg for 14 days
( once daily after food from day 1 to day 14 by oral route of administration)
Control Intervention1: PLACEBO: 500mg of pla
Sponsors
SRM COLLEGE OF PHARMACY , SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
Eligibility
Inclusion 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. 11. Negative urine test for drugs of abuse for morphine, barbiturates, benzodiazepines, amphetamine,THC & cocaine (to be performed on the day of check-in). 12. Negative alcohol breath analysis (to be performed on the day of check-in).
Exclusion criteria
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 9. Present or past history of intake of drugs which potentially modifies kinetics / dynamics of the study medication or any other medication judged to be clinically significant by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study is designed to evaluate the drug interaction potential of multiple oral dose of trans Resveratrol based on the pharmacokinetic parameters (AUC, Cmax, Tmax,t1/2,Cl,Vd) changes of Simvastatin Timepoint: 0.25,0.5,0.75,1.0,1.5,2,3,4,6,8 hrs on 15th day of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the ADRs during the study period.Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDR RC SATISH KUMAR
SRM COLLEGE OF PHARMACY
Outcome results
None listed