A Study on the Correlation of Drug Metabolism and Human Body Composition Based on the Bioequivalence Trial of Progesterone Sustained-release Vaginal Gel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Weight
时间窗: The day before using drug，and 1 to 4 days after using drug
Weight (kilogram) measured using a body weight scale.
Fat percentage (%)
时间窗: 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 (%)
Waist circumference
时间窗: 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）
次要结局
未报告次要终点