No phaseCompleted
Bioavailability of Seven Mitopure Formulations
A Comparative Pharmacokinetic Profiles of Urolithin A Formulations in Healthy Volunteers: a Randomized, Open-label, Single-dose, Parallel-arm Study
- Sponsor
- Amazentis SA (Industry)
- Enrolment
- 84 enrolled
- Conditions
- Healthy Adults
- Interventions
- Mitopure (Urolithin A)
- Ages
- adults
- Registry
- NCT06853197
From the registry
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.
Primary outcomes
- Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax)
- Exposure to Urolithin A over time measured as area under the curve (AUC)