Single dose, crossover bioavailability study to compare the Formulation A Berberine 95 percent with Formulation B Berberine 95 percent plus Turmeric and Formulation C Berberine 70 percent with Formulation D Berberine 70 percent plus Turmeric in healthy adult human subjects. - NI

Himalaya Wellness Company0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1) Male and/or non-pregnant, non-lactating female subjects with BMI from 18.5 to 30.0 kg/m2 (both inclusive).
•2) Healthy subjects according to medical history, screening assessments (lab and medical examinations).
•3) Subjects willing to provide written informed consent to participate in the study.

•1) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recordings, gynaecological history and present complaints (for female volunteers)].
•2) Subjects having foods containing high concentrations of turmeric or turmeric rich foods within the 14 days prior to drug administration.
•3) Subjects with positive serology for HIV and HbsAg.
•4) Subjects with usage of berberine supplements.
•5) History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
•6) Smoker who smokes 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
•7) Volunteer who has donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or more than 200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
•8) Intolerance to venipuncture

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