CTRI/2019/11/022135已完成未知
A double blind, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, crossover oral bioequivalence study of Product A (Xtenergy caffeine60%, 200 mg caffeine/ Capsule)of OmniActive Health Technologies Ltd., Indiaand Product B(Natural caffeine extract 99%,200 mg caffeine/Capsule)of OmniActive Health Technologies Ltd., Indiain healthy adult human subjects under fasting condition.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 26
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
- •1. Healthy, adult, human subjects within the age range of >= 18 <= 55 years
- •2. BMI between 18.5 â?? 24.9Kg/m2.
- •3. Coffee drinkers with 1-2 cups of coffee per day (no more than 16 cups of coffee per week).
- •4. Subject is a non-smoker and non-alcoholic.
排除标准
- •Institutionalized subjects.
- •Subjects having contraindications or hypersensitivity to study IP or related group of IP.
- •Systolic blood pressure less than 90 mm Hg or more than 130 mm Hg.
- •Diastolic blood pressure less than 60 mm Hg or more than 80 mm Hg.
- •Pulse rate less than 60 beats/minute or more than 100 beats/minute.
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