A Study on the Correlation of Drug Metabolism and Human Body Composition Based on the Bioequivalence Trial of Progesterone Sustained-release Vaginal Gel

Second Affiliated Hospital of Wenzhou Medical University

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Other

Identifiers

NCT07097246

SAHoWMU-CR2025-03-223

Details and patient eligibility

About

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? Healthy adult postmenopausal female subjects participating in the quality and efficacy consistency evaluation project for the generic progesterone vaginal sustained-release gel conducted at our hospital will undergo body composition analysis. By combining pharmacokinetic parameters and adverse drug reactions, the study will analyze differences in the metabolism of progesterone vaginal sustained-release gel 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.

Enrollment: 48 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

48 participants in 1 patient group

observation group