Effects of polyherbal formulation on cytochrome P450 enzymes mediated drug metabolism
- Registration Number
- CTRI/2014/02/004406
- Lead Sponsor
- SRM University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1. Healthy female volunteers of 18 to 45 years (both years inclusive).
2. Willing to give informed written consent and comply with the study requirements.
3. Subject should be able to communicate effectively.
4. Non-smokers and Non-Alcoholic.
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 â?? 139 mmHg systolic and 60 â?? 89 mmHg diastolic. Pulse rate should be within the range of 60 â?? 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.
1. Subjects 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. Pregnant or lactating women.
5. History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric or hematological systems, judged to be clinically significant.
6. History of dysphagia.
7. History of any medical disorder that is of significance in the investigatorâ??s opinion.
8. Present or past history of drug abuse.
9. History of hypersensitivity to study formulation.
10. History of allergy to vegetables and / or food substances and / or any other manifestations suggestive of hypersensitivity reactions.
11. Present or past history of intake of drugs which potentially modify kinetics / dynamics of study medication or any other medication judged to be clinically significant by the investigator.
12. Consumption of grapefruit / its products within 48 hours prior to the start of study.
13. Subject with clinically significant abnormal values of laboratory parameters.
14. Subject who had participated in any other clinical study during the last 3 months.
15. Subject who had bled in the past 3 months from the date of start of study either for blood donation or for any other reason.
16. History of habituation to coffee, tea or other xanthine containing products and inability to withhold the intake during the - in house - stay
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, tmax, plasma half life (t1/2) , AUC0-t and AUC0-inf, AUC at steady state, elimination rate constant (Kel), clearance (Cl), volume of distribution (Vd)Timepoint: 0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24th hour
- Secondary Outcome Measures
Name Time Method Safety (adverse events)Timepoint: Throughout study period