About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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 (%)
Weight
Weight (kilogram) measured using a body weight scale.
Sponsors and contacts
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