A clinical trial study to determine the oral bio-availability of Caffxtend capsules.

An open-label, balanced, randomized, single dose, two treatment, two sequence, two period, two way crossover oral bio-availability study comparing caffxtend capsules 200 mg (caffeine long acting beadlets 50N 400mg, equivalent to natural caffeine 200 mg, filled in to capsules) manufactured by Inventia healthcare limited with caffeine capsules 200 mg manufactured by Unicorn natural products ltd in healthy adult human subjects under fasting conditions. - CAFF

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/06/034185

Enrollment

Registered

2021-06-11

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: Caffxtend capsules: 200 mg Oral dose 20 days Control Intervention1: Caffeine capsules: 200 mg Oral dose 20 days

Eligibility

Inclusion criteria

Inclusion criteria: Body Mass Index between 18.50 to 29.99 kg/m2 Subjects who have no evidence of underlying diseases during screening Subjects whose screening laboratory values are within normal limits Healthy as documented by medical history, physical examination, vital sign assessments, 12 lead ECG, X-ray and realted clinical laboratory assessments. Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH & LH.

Exclusion criteria

Exclusion criteria: Evidence of allergy or known hypersensitivity to caffeine or any of the ingredients of the products. Any major illness in the last three months or any significant ongoing chronic medical illness. Renal or liver impairment. History or presence of alcohol addiction or abuse. Subjects who had participated in any other study within the 90 days of check-in.

Design outcomes

Primary

Measure	Time frame
To determine the oral bioavailability of different caffeine capsulesTimepoint: 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours	—

Secondary

Measure	Time frame
To monitor the safety and tolerability of a single dose administered in healthy human adult subjects under fasting conditionsTimepoint: 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours	—

Countries

India

Contacts

Public ContactDr R Senthurselvi

MBBS MD

senthurselvi.r@spinoslifescience.com

Outcome results