Healthy
Conditions
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? 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.
Interventions
None listed
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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. |
| Waist circumference | 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 Waist circumference（centimeter） |
Countries
China
Outcome results
None listed