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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observation group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other | We do not intervene with the subjects; we only observe their body composition data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%) | The day before using drug,and 1 to 4 days after using drug |
| Weight | Weight (kilogram) measured using a body weight scale. | The day before using drug,and 1 to 4 days after using drug |
| Waist circumference | 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) | The day before using drug,and 1 to 4 days after using drug |
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Inclusion Criteria:
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.
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The study population consists of subjects who participate in the bioequivalence trial of progesterone vaginal sustained-release gel conducted in the Phase I clinical trial ward of our hospital and who meet the inclusion and exclusion criteria of this trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital and Yuying Children's Hospital Affiliated to Wenzhou Medical University | Wenzhou | Zhejiang | 325802 | China |
There is not a plan to make IPD available.
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