Nutraceutical

Bioavailability Trial for a Novel Curcumin Formulation

Focus Area

Nutraceutical

Duration

5 months

Footprint

2 India sites, 60 subjects

Key Outcome

6.4x higher bioavailability vs standard

Overview

A randomized cross-over PK study established clean claim-substantiation evidence for a novel curcumin delivery system, aligned to FSSAI and DCGI expectations.

The Challenge

What we were asked to solve

A nutraceutical sponsor needed rigorous human-PK evidence to substantiate a bioavailability claim on a novel curcumin formulation — for regulatory dossier and label support.

Our Approach

How we delivered it

1Randomized, open-label, two-way cross-over PK design
260 healthy subjects, LC-MS/MS quantification with a validated bioanalytical partner
3eCRF + ePRO on our 21 CFR Part 11 validated CTMS
4FSSAI-aligned safety, tolerability and GI-symptom capture

Outcomes

6.4x higher bioavailability vs standard

6.4x higher bioavailability vs standard-curcumin comparator

Zero SAEs; mild GI events resolved without intervention

Full study report + statistical package delivered inside 5 months

Evidence pack accepted for sponsor's international label submission

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Focus AreaNutraceutical

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