To check the difference of two products that is product A (Xtenergy caffeine 60%, 200 mg caffeine/ Capsule) and product B (Natural caffeine extract 99%,200 mg caffeine/Capsule) in the healthy adult human beings.
Not Applicable
Completed
- Registration Number
- CTRI/2019/11/022135
- Lead Sponsor
- OmniActive Health Technologies Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
Inclusion Criteria
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.
Exclusion Criteria
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: 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.
- Secondary Outcome Measures
Name Time Method 1.To evaluate changes in Caffeine Research Visual Analogue Scales (Caff-VAS) consisting of seven visual analogue scales (relaxed, alert, jittery, tired, tense, headache, â??overall mood) from baseline (0.00 hr) to1hr, 2hr, 4hr, 6hr, 8hr, 10hr,and 12hr.Timepoint: 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.