NCT06362018

Bioavailability of Three Mitopure Formulations

Name: Clinical Trial NCT06362018
Creator: Amazentis SA
Keywords: Healthy Adults, Mitopure (Urolithin A), dietary supplement, clinical trial, India

A Comparative Pharmacokinetic Profiles of Three Urolithin A Formulations in Healthy Volunteers: A Randomized, Open-label, Single-dose, Parallel-arm Study

Amazentis SA·ClinicalTrials.gov·dietary supplementRecruiting

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Study focus

Disease/Condition: Healthy Adults
Drug/Device/Intervention: Mitopure (Urolithin A)
Study type: Interventional
Intervention type: dietary supplement

Sponsor & location

Primary sponsor: Amazentis SA
Location: Pune, India

Timeline & enrollment

Phase: N/A
Start date: May 07, 2024
End date: Jul 31, 2024
Enrollment: 36 participants

Primary outcome

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)

Summary

This study's design as an open-label, single-dose, randomized trial that aligns with the objective of characterizing the concentration-time profiles of three 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.

ICD-10 classifications

ObesityHealthy person accompanying sick personObesity, unspecifiedRoutine general health check-up of inhabitants of institutionsLifestyle-related condition

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06362018
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06362018 through Pure Global AI's free database. This phase not specified trial is sponsored by Amazentis SA and is currently Recruiting. The study focuses on Healthy Adults. Target enrollment is 36 participants.

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