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NCT06853197
Bioavailability of Seven Mitopure Formulations
NA trial testing Mitopure (Urolithin A) in Healthy Adults in 84 participants. Completed in 5 May 2025.
5 May 2025
Quick facts
| Lead sponsor | Amazentis SA |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 84 |
| Start date | 17 March 2025 |
| Primary completion | 5 May 2025 |
| Estimated completion | 5 May 2025 |
| Sites | 1 location across India |
Drugs / interventions tested
- Mitopure (Urolithin A)
Conditions studied
- Healthy Adults — all drugs for Healthy Adults →
Sponsor
Amazentis SA — full company profile →
Who can join
Adults 18 to 45, any sex, with Healthy Adults. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study's design as an open-label, single-period, single-dose, randomized trial that aligns with the objective of characterizing the concentration-time profiles of seven Urolithin A (Mitopure) formulations in a controlled setting. The inclusion criteria, stringent fasting requirements, standardized fluid intake and strict dietary restriction protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes. Ultimately, this clinical trial aims to contribute valuable insights into the pharmacokinetic behavior of the different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Mitophagy in the pathogenesis and management of disease.
Wang Q, Sun Y, Li TY, Auwerx J. · · 2026 · cited 1× · PMID 41486294 · DOI 10.1038/s41422-025-01203-7
Verify or expand the search:
- PubMed search for NCT06853197
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mitopure (Urolithin A)
Trials testing the same drug.
- NCT07231848 — Bioavailability of Four Mitopure Formulations · NA · completed
- NCT06556706 — Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults · NA · completed
- NCT06362018 — Bioavailability of Five Mitopure Formulations · NA · completed
Other recruiting trials for Healthy Adults
Currently open trials in the same condition.
- NCT07454551 — The Comparison of Different Passive Warm-Up Methods Prior to Exercise · NA · recruiting
- NCT07431853 — A Study to Learn About mRNA Vaccines Against Influenza in Adults · Phase 2 · recruiting
- NCT07362550 — Effects of 12-Week Balanced Diet on Body Composition & Metabolic Parameters in Twins · NA · recruiting
- NCT07284173 — A Study to Learn if a Medicine That Reduces Stomach Acid Affects the Blood Level of Study Medicine PF-08049820 in Health · Phase 1 · active not recruiting
- NCT07518758 — Acute Effect of Polyphenols Supplementation on Endothelial Function and Exercise Related Markers, in Physically Active H · NA · active not recruiting
Other Amazentis SA trials
Trials by the same sponsor.
- NCT07517913 — Cerebrospinal Fluid Kinetics of Urolithin A · NA · not yet recruiting
- NCT07517874 — Human Skin Safety Testing of 1 Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volun · NA · not yet recruiting
- NCT07517887 — Anti-aging Efficacy Study on One Cosmetic Product Containing Mitopure · NA · not yet recruiting
- NCT07517900 — Human Skin Safety Testing of 1 Mitopure Topical Product Using a Clinical Safety in Use Study in Healthy Volunteers · NA · not yet recruiting
- NCT07231783 — The Effect of Urolithin A (Mitopure®) Supplementation on Muscle Strength in Healthy Middle-Aged Adults · NA · recruiting
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 NCT06853197 (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 Amazentis SA
- Last refreshed: 21 May 2025
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/NCT06853197.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing