CTRI/2021/01/030805
Completed
N/A
Clinical Pharmacokinetic drug interaction potential of Maha yogaraja Gugglu Tablet(MYG) Tablet in Adult, Healthy, Human volunteers: A Randomized, double blindplacebo-controlled trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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