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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-25

Study Completion Date

2024-12-18

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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observation group

Intervention Type OTHER

We do not intervene with the subjects; we only observe their body composition data.

Interventions

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We do not intervene with the subjects; we only observe their body composition data.

Intervention Type OTHER

Eligibility Criteria

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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）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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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SAHoWMU-CR2025-03-223

Identifier Type: -

Identifier Source: org_study_id