Clinical Pharmacokinetic drug interaction potential of Maha yogaraja Gugglu Tablet(MYG) Tablet in Adult, Healthy, Human volunteers

Not Applicable

Completed

• Registration Number: CTRI/2021/01/030805
• Lead Sponsor: SRM INSTITUTE OF SCIENCE AND TECHNOLOGY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

�Healthy male volunteers of 18 to 45 years (both years inclusive) and body weight > 50 kg.

�Willing to give informed written consent and comply with the study requirements.

�Subject should be able to communicate effectively.

�Non-smokers or individuals who smoke less than 5 cigarettes per day

�Teetotalers or individuals who drink less than 60 ml of high-alcohol-content liquor or 120 ml of low-alcohol-content liquor

� Body Mass Index (BMI) between 18.50 and 24.99 Kg/m2

�Healthy individuals as evaluated by personal history, medical history and general clinical examination.

ââ?¬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.

�Normal biochemical, hematological and urinary parameters.

�Normal Chest X-ray PA view & ECG in 12 leads.

�Negative for HIV 1 & 2, Hepatitis B, Hepatitis C and Syphilis tests.

�Negative urine test for drugs of abuse for morphine, barbiturates, benzodiazepines, amphetamine, THC & cocaine (to be performed on the day of check-in).

�Negative alcohol breath analysis (to be performed on the day of check-in)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified