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

N/ARecruitingNCT07611929

Second Affiliated Hospital of Wenzhou Medical University3,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Healhty

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

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 (%)

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

Weight

Weight (kilogram) measured using a body weight scale.