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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07611929

Enrollment

3000

Registered

2026-05-28

Start date

2024-10-05

Completion date

2029-12-31

Last updated

2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healhty

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion criteria

1. Participants who have been successfully enrolled in the bioequivalence trials of Progesterone Sustained-release vaginal gel； 2. 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.

Exclusion criteria

1: 1）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.

Design outcomes

Primary

Measure	Time frame	Description
Fat percentage (%)	The day before using drug，and 1 to 4 days after using drug	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 (%)
Weight	The day before using drug，and 1 to 4 days after using drug	Weight (kilogram) measured using a body weight scale.

Countries

China

Contacts

CONTACTTING LI

liting1021@aliyun.com0577-88002664

Outcome results