A single-dose, single period of comparing Formulated Curcumin based drink with Unformulated Curcumin based drink manufactured by Sipwise Beverage Pvt Ltd, in healthy, subjects under fed conditions.

Phase 1

Completed

• Registration Number: CTRI/2020/09/027701
• Lead Sponsor: Dr Srividhya Sundararaman

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: 8

Inclusion Criteria

Healthy adult human volunteers of age between 18-45 years

Exclusion Criteria

Evidence of allergy or known hypersensitivity to Curcumin and its inactive ingredients.

Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver

disease, alcohol abuse and recently overcome or active existing tinnitus.

Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with

or without coma.

Any major illness in the last three months or any significant ongoing chronic medical

illness.

Any disease or condition which might compromise the haemopoeitic, gastrointestinal,renal, hepatic, cardiovascular, musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.

History of drug abuse within 03 months (including benzodiazepines, opioids, cocaine,

barbiturates, THC and amphetamine etc.)

History of alcohol addiction or abuse.

History of difficulty in swallowing.

History of difficulty in accessibility of veins.

Any blood donation / excess blood loss within 90 days of check-in.

Subject who had participated in any other study within the 90 days of study check-in.

Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea,

chocolate, and caffeine-containing sodas, colas, etc.) and tobacco containing products

for at least 24.00 hours prior to check-in and throughout the entire study.

Consumption of alcohol and its products, grapefruit and/ or its juice and poppy

containing foods within 72.00 hours prior to clinic admission and throughout the entire

study.

Use of any prescribed medication within 14 days and any over the counter medicinal

products, herbal medications, etc. within 07 days prior to study check in and throughout

the study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Bio availabilityTimepoint: 18 time points, 00.00, 00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 24.00

Secondary Outcome Measures

Name	Time	Method
To assess the safety of trial subjects during the study.Timepoint: 18 time points, 00.00, 00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 24.00