No phaseCompleted
Bioavailability of Four Mitopure Formulations
Comparative Pharmacokinetics of Urolithin A (Mitopure) Formulations in Healthy Adults: a Randomized, Open-label, Single-dose, Parallel-arm Study
- Sponsor
- Amazentis SA (Industry)
- Enrolment
- 48 enrolled
- Conditions
- Healthy Adults
- Interventions
- Mitopure (Urolithin A)
- Ages
- adults
- Registry
- NCT07231848
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 four 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)