Last reviewed · How we verify
NCT06732908: Berberine Safe
Safety Profile of a New Berberine Formulation with Improved Bioavailability
NA trial testing LipoMicel Berberine in Safety in 19 participants. Completed in 31 October 2024.
27 August 2024
Quick facts
| Lead sponsor | Isura |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | other |
| Enrollment | 19 |
| Start date | 27 May 2024 |
| Primary completion | 27 August 2024 |
| Estimated completion | 31 October 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- LipoMicel Berberine
- Placebo
Conditions studied
- Safety — all drugs for Safety →
Sponsor
Isura
Who can join
Adults 21 to 65, any sex, with Safety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to evaluate important safety markers related to liver- and kidney function in healthy individuals after treatment with a new formulation, LipoMicel Berberine. The main question this research aims to answer is: Is the new formulation of Berberine (LipoMicel) with improved bioavailability safe and well tolerated in healthy individuals? Participants will: 1. Take 1000 mg (2 capsules/d) of LipoMicel Berberine orally for a maximum period of 30 days. 2. Return to study site weekly for blood tests. 3. Keep a diary of their symptoms (collection of adverse events).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A 30-Day Randomized Crossover Human Study on the Safety and Tolerability of a New Micellar Berberine Formulation with Improved Bioavailability.
Ibi A, Chang C, Kuo YC, Zhang Y, et al · · 2025 · cited 2× · PMID 40278369 · DOI 10.3390/metabo15040240
Verify or expand the search:
- PubMed search for NCT06732908
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Isura trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06732908 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Isura
- Last refreshed: 13 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06732908.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing