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

Phase 1

Completed

• Registration Number: CTRI/2021/06/034185
• Lead Sponsor: Inventia Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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

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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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, <br/ ><br>12.00, 24.00, 36.00 and 48.00 hours

Secondary Outcome Measures

Name	Time	Method
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, <br/ ><br>12.00, 24.00, 36.00 and 48.00 hours