Drug Metabolism, Excretion, and Human Body Composition of Aximus Capsules

Second Affiliated Hospital of Wenzhou Medical University26 enrolled

Overview

This project will be based on the bioequivalence test of Aximus capsules, measuring the body composition indicators of healthy subjects before and after medication, and collecting urine samples from subjects at different time periods after medication, measuring urine drug concentration, calculating urine excretion, analyzing the individualized differences in metabolism and excretion of Aximus capsules under different health states of human components, and providing guidance for clinical precision medication.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bioequivalence Trial

Interventions

Aximus capsules（test）OTHER

Aximus capsules test preparation

Aximus capsules（reference）DRUG

Aximus capsules reference preparation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy adult men and non-pregnant non-lactating women who successfully participated in the bioequivalence test of acylimus capsules； 2. Signed the informed consent form, and fully understood the content, process and risks of this research, and be able to communicate well with the researchers. Exclusion Criteria: 1. Female subjects who are menstruating (which may affect urine sample collection); 2. The subjects may not be able to complete this study for other reasons or may not be suitable to participate in this study.

Locations (1)

The Second Affiliated Hospital of WMU Phase l Clinical Trial Unit /Center Of Bioequivalence Study

Wenzhou, China

Outcomes

Primary Outcomes

Excretion volume

drug concentration in urine

Time frame: Within 12 hours after taking medication

Data from ClinicalTrials.gov

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