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Bioavailability of Three Mitopure Formulations - Trial NCT06362018

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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NCT06362018
Recruiting
dietary supplement
Trial Details
ClinicalTrials.gov โ€ข NCT06362018
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Bioavailability of Three Mitopure Formulations
A Comparative Pharmacokinetic Profiles of Three Urolithin A Formulations in Healthy Volunteers: A Randomized, Open-label, Single-dose, Parallel-arm Study

Study Focus

Healthy Adults

Mitopure (Urolithin A)

Interventional

dietary supplement

Sponsor & Location

Amazentis SA

Pune, India

Timeline & Enrollment

N/A

May 07, 2024

Jul 31, 2024

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

Obesity
Healthy person accompanying sick person
Obesity, unspecified
Routine general health check-up of inhabitants of institutions
Lifestyle-related condition

Data Source

ClinicalTrials.gov

NCT06362018

Non-Device Trial