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

NCT07141368 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-26

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

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

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Sanjay Vaze, MBBS · Vedic Lifesciences Pvt.Lts

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-11-01
Completion
2025-11-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07141368 on ClinicalTrials.gov