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.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To compare the oral bioavailability between Formulations A and B and between Formulations C and D by analyzing plasma samples using LC-MS/MS method specific for the determination of berberine.
概览
简要总结
This is an open label, randomized, comparative, two-period, four-treatment, two-sequence, crossover, balanced, single dose oral bioavailability study to compare the [Formulation A: Berberine 95% with Formulation B: Berberine 95% + Turmeric] and [Formulation C: Berberine 70% with Formulation D: Berberine 70% + Turmeric] in healthy adult, human subjects.
Total expected duration of the clinical part is 09 Days from the day of check-in of first period.
The following PK parameters will be measured: Cmax, AUCt, AUCi, Tmax, Kel, AUC_%Extrap_obs and tHalf.
研究设计
- 研究类型
- Ba/be
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and/or non-pregnant, non-lactating female subjects with BMI from 18.5 to 30.0 kg/m2 (both inclusive).
- •Subjects willing to provide written informed consent to participate in the study.
排除标准
- •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)].
- •Subjects having foods containing high concentrations of turmeric or turmeric rich foods within the 14 days prior to drug administration.
- •Subjects with positive serology for HIV and HbsAg. 4) Subjects with usage of berberine supplements.
- •History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- •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.
- •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.
- •Intolerance to venipuncture.
结局指标
主要结局
To compare the oral bioavailability between Formulations A and B and between Formulations C and D by analyzing plasma samples using LC-MS/MS method specific for the determination of berberine.
时间窗: Pre-dose (0.0 hour), 0.25, 0.50, 1.00, 2.00, 4.00 and 8.00 hours (within +2 mins of schedule time) post dose for period 1 and 2.
次要结局
- To monitor the safety and tolerability of the subjects.(Pre-dose (0.0 hour), 0.25, 0.50, 1.00, 2.00, 4.00 and 8.00 hours (within plus 2 mins of scheduled time) post dose for period 1 and 2)
研究者
Dr Simran Sethi MBBS
Cliantha Research