NCT07141368

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

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is an open-label, randomized, balanced, single oral dose, four-treatment, four-sequence, four-period, four-way cross-over comparative bioavailability trial designed to assess the bioavailability of different curcumin formulations in healthy adult volunteers under fasting conditions. A total of 24 subjects will be enrolled, each receiving four investigational products in a randomized sequence: non-formulated curcumin (90 mg, 1 capsule), Curcumin Dispersome formulation (600 mg; 2 x 300 mg capsules, each containing 90 mg curcumin), Turmipure Gold™ (300 mg, 1 capsule), and Qunol, Turmeric, Curcumin Complex, Extra Strength (1000 mg; 2 x 500 mg capsules). Each product will be administered as a single oral dose with 240 mL of water after at least 10 hours of fasting. Subjects will be housed in the clinical facility for at least 36 hours prior to dosing and remain for at least 24 hours post-dose during each period, with a minimum 7-day washout between periods. Safety will be monitored through clinical examination, vital signs, ECG, and laboratory assessments throughout the study. Blood samples for pharmacokinetic analysis will be collected at 13 time points in each period, and subjects will receive standardized turmeric-free meals and adhere to strict dietary and medication restrictions. The primary objective is to compare the bioavailability of the investigational products, with secondary objectives including the evaluation of safety and tolerability in the study population.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-08-26
• Last updated: 2025-08-26

Locations

1 site across 1 country: India