Correlation Studies on Human Body Composition Based on Bioequivalence or Pharmacokinetic Trials
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
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? 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.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
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.
