Correlation Studies on Human Body Composition Based on Bioequivalence or Pharmacokinetic Trials

NCT07611929 | Recruiting

• 1 other identifier: SAHoWMU-CR2025-03-224
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to investigate the impact of body composition on the absorption, distribution, and metabolism of drugs. The primary question it seeks to answer is: Does body composition affect the absorption, distribution, and metabolism of drugs? By combining pharmacokinetic parameters and adverse drug reactions, the study will analyze differences in the metabolism of drugs under various body composition conditions. During the Phase I clinical trial, under the guidance of the researchers, subjects will use the non-invasive InBody S10 body composition analyzer to obtain body composition data, including but not limited to inorganic salts, muscle mass, lean body mass, body weight, and body fat percentage.

Conditions

Healhty

Outcome Measures

Primary Outcomes (2)

• Fat percentage (%)

  Using a body composition analyzer：Inbody S10, non-invasively obtain the subject's body composition data。This instrument applies a very small electrical current to the body and obtains data on various body components based on the characteristics of different body compositions, including fat percentage (%)

  The day before using drug，and 1 to 4 days after using drug

• Weight

  Weight (kilogram) measured using a body weight scale.

  The day before using drug，and 1 to 4 days after using drug

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of subjects who participate in the bioequivalence trials in the Phase I clinical trial ward of our hospital and who meet the inclusion and exclusion criteria of this trial.

You may qualify if:

• Participants who have been successfully enrolled in the bioequivalence trials of Progesterone Sustained-release vaginal gel；
• Have signed the informed consent form, have a full understanding of the content, process, and risks of this study, and can communicate well with the researchers.

You may not qualify if:

• ）Participants who may not be able to complete the study for other reasons or are deemed by the investigator to be unsuitable for participation in this study.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital and Yuying Children's Hospital Affiliated to Wenzhou Medical University

Wenzhou, Zhejiang, 325802, China

RECRUITING

Central Study Contacts

TING LI

CONTACT

0577-88002664; liting1021@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: October 5, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 28, 2026

Record last verified: 2025-07

Locations

CN (1)