CTRI/2021/06/034185已完成1 期
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. - CAFF
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
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
- •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.
研究者
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