CTRI/2021/01/030805已完成未知
Clinical Pharmacokinetic drug interaction potential of Maha yogaraja Gugglu Tablet(MYG) Tablet in Adult, Healthy, Human volunteers: A Randomized, double blindplacebo-controlled trial
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- •Ã¢â?¬Â¢Healthy male volunteers of 18 to 45 years (both years inclusive) and body weight > 50 kg.
- •Ã¢â?¬Â¢Willing to give informed written consent and comply with the study requirements.
- •Ã¢â?¬Â¢Subject should be able to communicate effectively.
- •Ã¢â?¬Â¢Non-smokers or individuals who smoke less than 5 cigarettes per day
- •Ã¢â?¬Â¢Teetotalers or individuals who drink less than 60 ml of high-alcohol-content liquor or 120 ml of low-alcohol-content liquor
- •Ã¢â?¬Â¢ Body Mass Index (BMI) between 18.50 and 24.99 Kg/m2
- •Ã¢â?¬Â¢Healthy individuals as evaluated by personal history, medical history and general clinical examination.
- •Ã¢â?¬Â¢Vital parameters - BP should be within the range of 100 ââ?¬â?? 139 mmHg systolic and 60 ââ?¬â?? 89 mmHg diastolic. Pulse rate should be within the range of 60 ââ?¬â?? 100 / min. Oral temperature between 97.8Ã?Å¡ F and 99.0 Ã?Å¡ F. Respiratory rate should be within the range of 14-18/min.
- •Ã¢â?¬Â¢Normal biochemical, hematological and urinary parameters.
- •Ã¢â?¬Â¢Normal Chest X-ray PA view & ECG in 12 leads.
- •Ã¢â?¬Â¢Negative for HIV 1 & 2, Hepatitis B, Hepatitis C and Syphilis tests.
- •Ã¢â?¬Â¢Negative urine test for drugs of abuse for morphine, barbiturates, benzodiazepines, amphetamine, THC & cocaine (to be performed on the day of check-in).
- •Ã¢â?¬Â¢Negative alcohol breath analysis (to be performed on the day of check-in)
排除标准
- •1) History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric or hematological systems, judged to be clinically significant
- •2) subjects incapable of understanding the informed consent and not willing to participate in the study
- •3) hypersensitivity to study formulation
- •4) history of drug abuse
- •5) history of hypersensitivity to study drug and allergic to any vegetables or foods
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