An open-label, balanced, randomized, single-dose, two-treatment, two-period, two-way crossover, relative bioavailability study of two different formulations of Curcumin 10 mg orally soluble tablet manufactured by KMS Health Center Pvt. Ltd., East Tambaram, Selaiyur, Chennai and Curcunex G 5 mg manufactured by Stabicon Life Science Pvt. Ltd., Plot No 28, Bommasandra industrial area (Sub layout), 4th Phase, Jigani Hobli, Anekal Taluk, Bangalore, Karnataka- 560100. Marketed by Yeus Life science Pvt Ltd, A-IO, Art gold house, Lbs Marg, Mumbai 400070 in healthy, adult, human, male subjects under fasting conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the Relative Bioavailability of different formulations of Curcumin tablets in healthy adult human male subjects under fasting conditions.
研究概览
简要总结
Toassess the relative bioavailability of different Curcumin formulations and to monitor the safety andtolerability of a single dose administered in healthy adult human male subjectsunder fasting conditions.Employingthe estimated concentration vs. time profiles ofTotal Curcuminusing WinNonlin® version 8.1 or higherversion of Pharsight Corporation, USA, or SAS® system for windows version 9.4 or above (SAS®Institute Inc., USA) or applicable software the following pharmacokineticparameters
Primaryparameters are: Cmax, AUC0-t & AUC0-Â¥.
Secondary parameters are: tmax,Kel, t½.&
Statistical analyses for Total Curcumin (will bedone using R-Software or SAS® system for windows version 9.4 orabove (SAS® Institute Inc., USA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Normal, healthy, adult, human male subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2 Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21days of check-in.
- •Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance.
- •Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
- •Willing to comply with all requirements of this study protocol as well as instructed by the study personnel.
排除标准
- •Evidence of allergy or known hypersensitivity to Curcumin or its inactive ingredients.
- •Renal or liver impairment.
- •Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
- •History of alcohol addiction or abuse.
- •Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) tobacco containing products for at least 48.00 hours prior to check-in and throughout the entire study.
- •Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 72.00 hours prior to check-in and throughout the entire study.
- •History difficulty in swallowing, accessibility of veins.
- •Positive results for urine screen of drugs of abuse (Marijuana-THC, amphetamine-AMP, barbiturates-BAR, cocaine-COC, benzodiazepines-BZD and morphine-MOR) in urine prior to check-in of each period.
结局指标
主要结局
To assess the Relative Bioavailability of different formulations of Curcumin tablets in healthy adult human male subjects under fasting conditions.
时间窗: 00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00,10.00, 12.00 and 24.00 hours.
次要结局
- To monitor the safety and tolerability of a single dose administered in healthy adult human male subjects under fasting conditions.(00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00,10.00, 12.00 and 24.00 hours.)