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
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To compare the rate and extent of absorption of Product A (Xtenergy caffeine 60%, 200 mg caffeine/ Capsule)of OmniActive Health Technologies Ltd., India and Product B(Natural caffeine extract 99%, 200 mg caffeine/Capsule)of OmniActive Health Technologies Ltd., Indiain healthy human adult subjects under fastingcondition.
研究概览
简要总结
To comparethe rate and extent of absorption of Product A (Xtenergycaffeine 60%, 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 humanadult subjects under fastingcondition.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy, adult, human subjects within the age range of ≥ 18 ≤ 55 years
- •BMI between 18.5 – 24.9Kg/m
- •Coffee drinkers with 1-2 cups of coffee per day (no more than 16 cups of coffee per week).
- •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.
结局指标
主要结局
To compare the rate and extent of absorption of Product A (Xtenergy caffeine 60%, 200 mg caffeine/ Capsule)of OmniActive Health Technologies Ltd., India and Product B(Natural caffeine extract 99%, 200 mg caffeine/Capsule)of OmniActive Health Technologies Ltd., Indiain healthy human adult subjects under fastingcondition.
时间窗: In each period the pre-dose samples at -4.00, 0.00 hr (1 x 04 mL) and post-dose blood samples (1 x 04 mL) at0.25, 0.50, 0.75, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, and 24.00hours will be collected.
次要结局
- 1.To evaluate changes in Caffeine Research Visual Analogue Scales (Caff-VAS) consisting of seven visual analogue scales ("relaxed", "alert", "jittery", "tired", "tense", "headache", “overall mood") from baseline (0.00 hr) to1hr, 2hr, 4hr, 6hr, 8hr, 10hr,and 12hr.(In each period the pre-dose samples at -4.00, 0.00 hr (1 x 04 mL) and post-dose blood samples (1 x 04 mL) at0.25, 0.50, 0.75, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, and 24.00hours will be collected.)