CTRI/2023/02/049518已完成未知
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 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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.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).
排除标准
- •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.
研究者
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