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NOT YET RECRUITING
NCT07141368
NA

Single Oral Dose Comparative Bioavailability Study of Investigational Product in Healthy Human Subjects Under Fasting Conditions.

Sponsor: Vedic Lifesciences Pvt. Ltd.

View on ClinicalTrials.gov

Summary

The sponsor has developed new curcuminoid formulations with the expectation of enhanced bioavailability compared to existing benchmark products. This study aims to evaluate the comparative bioavailability and characterize the pharmacokinetic profile of the test formulations in comparison to the reference formulations in healthy adult subjects under fasting conditions.

Official title: An Open Label, Randomized, Balanced, Four-Treatment, Four-Sequence, Four-Period, Four-way Crossover, Single Oral Dose Comparative Bioavailability Study of Curcumin in Healthy Human Subjects Under Fasting Conditions.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-09-01

Completion Date

2025-11-01

Last Updated

2025-08-26

Healthy Volunteers

Yes

Interventions

OTHER

Curcumin Dispersome formulation

75% BLG (600 mg (2 capsules of 300 mg each, containing 90 mg curcumin per capsule

OTHER

Non-formulated Curcumin

dose: 90 mg, 1 capsule

OTHER

Benchmark Formulation 1 - Turmipure Gold™

recommended daily dose: 300 mg, 1 capsule

OTHER

Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strength

recommended daily dose: 1000 mg, 2 capsules of 500 mg each

Locations (1)

IndiGlobal Labs Pvt. Ltd

Hyderabad, Telangana, India