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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022135
Enrollment
26
Registered
2019-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Xtenergy caffeine 60%, 200 mg caffeine/ Capsule: Xtenergy caffeine 60%, 200 mg caffeine/ Capsule. OmniActive Health Technologies Ltd Dose: 200 mg caffeine for 1 day Orally with 240 ±

Sponsors

OmniActive Health Technologies Ltd
Lead Sponsor
ClinSync Clinical Research PVt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy, adult, human subjects within the age range of >= 18 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

India

Contacts

Public ContactDr T Harish Ramnarayan

ClinSync Clinical Research Pvt Ltd

harishramnarayan.t@clinsynccro.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026