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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
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.
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- 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.)