An open-label, balanced, randomized, single dose, two treatment, two sequence, two period, two way crossover oral bio-availability study comparing caffxtend capsules 200 mg (caffeine long acting beadlets 50N 400mg, equivalent to natural caffeine 200 mg, filled in to capsules) manufactured by Inventia healthcare limited with caffeine capsules 200 mg manufactured by Unicorn natural products ltd in healthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To determine the oral bioavailability of different caffeine capsules
研究概览
简要总结
Caffeine belongs to the methyl xanthine class used for a variety of purposes, including certain respiratory conditions of the premature newborn, pain relief, and to combat drowsiness. Caffeine is similar in chemical structure to Theophylline andTheobromine.
A clinical trial study to determine the oral bioavailability of caffeine capsules. In each period subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 48.00 hours post-dose and the washout period of at least 04 days from the successive dosing day.
Pharmacokinetic & Statistical Parameters:
Employing the estimated concentration vs. time profiles of Caffeine using SAS® software Version 9.4 or higher version of SAS Institute Inc., USA or applicable software, the following pharmacokinetic parameters will be calculated:
Primary parameters are Cmax, AUC0-t & AUC0-ï‚¥.
Secondary parameters are tmax, Kel, t½and AUC_%Extrap_obs.
Statistical analysis for Caffeine will be done using SAS® software Version 9.4 or higher version of SAS Institute Inc., USA.
Caff-VAS Questionnaires at different time points will be analyzed. The mean and change from baseline will be analyzed and treatments will be compared using appropriate statistical method.
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
- All
入选标准
- •Body Mass Index between 18.50 to 29.99 kg/m2 Subjects who have no evidence of underlying diseases during screening Subjects whose screening laboratory values are within normal limits Healthy as documented by medical history, physical examination, vital sign assessments, 12 lead ECG, X-ray and realted clinical laboratory assessments.
- •Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH & LH.
排除标准
- •Evidence of allergy or known hypersensitivity to caffeine or any of the ingredients of the products.
- •Any major illness in the last three months or any significant ongoing chronic medical illness.
- •Renal or liver impairment.
- •History or presence of alcohol addiction or abuse.
- •Subjects who had participated in any other study within the 90 days of check-in.
结局指标
主要结局
To determine the oral bioavailability of different caffeine capsules
时间窗: 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00, | 12.00, 24.00, 36.00 and 48.00 hours
次要结局
- To monitor the safety and tolerability of a single dose administered in healthy human adult subjects under fasting conditions(00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00,)