An open label and single dose pharmacokinetic study of Mangiferin present in the polyherbal formulation of Salacia oblonga, Salacia roxburghii, Garcinia indica and Lagestroemia parviflora in healthy, adult, male, human subjects under fasting conditions

SRM University0 个研究点目标入组 10 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

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