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Bioavailability of Five Mitopure Formulations

NCT06362018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-10

No results posted yet for this study

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 five 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.

Conditions

  • Healthy Adults

Interventions

DIETARY_SUPPLEMENT

Mitopure (Urolithin A)

Mitopure (Urolithin A) is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health

Sponsors & Collaborators

  • Mprex Healthcare Pvt. Ltd.

    collaborator UNKNOWN

  • Amazentis SA

    lead INDUSTRY

Principal Investigators

  • Dr Ramshyam Agarwal, MD · Lokmanya Medical Research Centre and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2025-03-14
Completion
2025-03-14

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06362018 on ClinicalTrials.gov