Assessment of safety and efficacy of Nutraceutical supplements/AYUSH medicines in healthy human volunteers. - NI

HERBOLAB INDIA PVT LTD0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

试验速览

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•1. Healthy male and female human trial participants aged between 18 and 60 years (both inclusive);2. Female trial participants must have a negative urine pregnancy test prior to the housing;3. Male and females agreeing to use the contraceptive pill or abstinence as a method of contraception during and 07 days after completion of the study;4. Trial participants with a BMI between 18.50-29.90 kg per m2 and body mass, not less than 50.00 kg;5. Trial participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests).

•1.Incapable of understanding the informed consent information;
•2.Clinically significant medical condition, such as, but not limited to,
•cardiovascular, neurological, psychiatric, pulmonary, renal,
•immunological, endocrine (including uncontrolled diabetes or thyroid
•disease), or uncontrolled haematological abnormalities;
•3.History or presence of alcoholism or drug abuse;
•4.History or presence of cancer;
•5.Use of any prescribed medication (including herbal remedies)
•during the two weeks before the start of the study or OTC medicinalproducts (including herbal remedies) during the week before study initiation and throughout the study;
•6.Major illness during the 90 days before screening;
•7.Pregnant women and nursing mothers;
•8.Males and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study;
•9.Consumption of dietary supplements likely to provide
•constituents similar to the investigational product in last 3 days.

发起方

HERBOLAB INDIA PVT LTD