Bio availability study of Mangiferin from polyherbal formulatio
- Registration Number
- CTRI/2014/01/004271
- Lead Sponsor
- SRM University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Healthy male volunteers of 18 to 45 yrs (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.
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 97.8Ë? F and 99.0 Ë? 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).
Subjects incapable of understanding the informed consent.
History of any major surgical procedure in the past 3 months.
History of diabetes mellitus, tuberculosis and systemic hypertension.
History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric or hematological systems, judged to be clinically significant.
History of dysphagia.
History of any medical disorder that is of significance in the investigatorâ??s opinion.
Present or past history of drug abuse.
History of hypersensitivity to study formulation.
History of allergy to vegetables and / or food substances and / or any other manifestations suggestive of hypersensitivity reactions.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, Tmax, AUC0-t, AUC0-inf , Kel rate of elimination <br/ ><br>and half life T1/2, Clearance will be reported <br/ ><br>Timepoint: 01.00, 02.00, 03.00, 03.30, 04.00, 04.30, 05.50, 06.50, 08.00, 10.00,16.00 and 24.00 hours post dose (Total of 12 samples - 5 mL each)
- Secondary Outcome Measures
Name Time Method ADVERSE DRUG REACTIONS (SAFETY OF DRUG)Timepoint: Through out the pharmacokinetic study and post 6 days