Comparing the Pharmacological Profile of Different Berberine Formulations, and Their Effects on Blood Sugar Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- AUC: the area under the concentration-time curve
研究概览
简要总结
The primary objective of this study is to evaluate the gastrointestinal absorption of berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing it with free berberine (hydrochloride) formulation. Several pharmacokinetic parameters are compared.
As secondary objective, the immediate or short-term effects of Berberine supplementation on blood sugar levels in healthy volunteers are evaluated via a glucose tolerance test (OGTT) using a portable glucometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-65
- •healthy, good physical condition
排除标准
- •Pregnancy or breast-feeding
- •Gastrointestinal conditions
- •Acute or chronic liver disease
- •Acute or chronic kidney disease
- •Acute or chronic cardiovascular disease
- •Hematological disease
- •Allergy or Intolerance to gluten
- •Allergy or Intolerance to Berberine
- •Use of any form of nicotine or tobacco
- •Alcohol and substance abuse history
- •Use of medications (e.g., blood sugar-lowering agents, or statins)
- •Use of Berberine supplements
- •Participation in another investigational study
结局指标
主要结局
AUC: the area under the concentration-time curve
时间窗: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the Area under the plasma concentration versus time curve (AUC) with that of with free/regular berberine (hydrochloride).
Cmax: maximum plasma concentration
时间窗: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the Peak Plasma Concentration (Cmax) with that of with free/regular berberine (hydrochloride).
Tmax: the time point of maximum plasma concentration
时间窗: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the time point of maximum plasma concentration (Tmax) with that of with free/regular berberine (hydrochloride).
次要结局
- Effects on Blood sugar levels(0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose))
- Changes in Blood sugar concentrations(0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose))