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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bioequivalence Trial

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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test preparation

Aximus capsules（test）

Intervention Type OTHER

Aximus capsules test preparation

reference preparation

Aximus capsules（reference）

Intervention Type DRUG

Aximus capsules reference preparation

Interventions

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Aximus capsules（test）

Aximus capsules test preparation

Intervention Type OTHER

Aximus capsules（reference）

Aximus capsules reference preparation

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes