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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorVedic Lifesciences Pvt. Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

9.5.1 Able and willing to participate in the study by complying with the protocol procedures as evidenced by a dated and signed informed consent form 9.5.2 Age greater than equal to 18 less than equal to 45 years. 9.5.3 Willing to consume the study product and donate blood. 9.5.4 BMI from 18.5 to 29.9 kg/m². 9.5.5 Subject with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable limits.

Disqualifiers

9.6.1 Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract or may affect absorption of IP and blood forming organ.

Trial design

Treatments tested in this trial

  • Curcumin Dispersome formulation
  • Non-formulated Curcumin
  • Benchmark Formulation 1 - Turmipure Gold™
  • Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strength

Treatment groups

24 Participants
are divided into 4 treatment groups

Sponsors and collaborators