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

ConditionHealhty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSecond Affiliated Hospital of Wenzhou Medical University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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 (%)

Time frame
The day before using drug,and 1 to 4 days after using drug
2

Weight

Weight (kilogram) measured using a body weight scale.

Time frame
The day before using drug,and 1 to 4 days after using drug

Secondary outcomes

Other outcomes

Sponsors and contacts

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