CTRI/2014/02/004406已完成1 期
Effects of novel polyherbal formulation on cytochrome P450 enzymes mediated drug metabolism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
研究者
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