Bioequivalence TrialNCT06307132
Drug Metabolism, Excretion, and Human Body Composition of Aximus Capsules
An observational study of Bioequivalence Trial, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Trial
- What is being tested?
- Aximus capsules（test） and Aximus capsules（reference）
- Type of treatment
- Pill or oral medicine
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Healthy adult men and non-pregnant non-lactating women who successfully participated in the bioequivalence test of acylimus capsules；
- 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.
Who cannot join
- Female subjects who are menstruating (which may affect urine sample collection);
- The subjects may not be able to complete this study for other reasons or may not be suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of WMU Phase l Clinical Trial Unit /Center Of Bioequivalence Study
Wenzhou
About this study
Official title: A Study on the Correlation of Drug Metabolism, Excretion, and Human Body Composition Based on the Bioequivalence Trial of Aximus Capsules
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.
- Conditions
- Bioequivalence Trial
- Being tested
- Aximus capsules（test）, Aximus capsules（reference）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aximus capsules（test）Other
Aximus capsules test preparation
Aximus capsules（reference）Drug
Aximus capsules reference preparation
| Study group | Role | What they receive |
|---|---|---|
| test preparation | Not described Receives: Other: Aximus capsules（test） | |
| reference preparation | Not described Receives: Drug: Aximus capsules（reference） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excretion volume
drug concentration in urine
Measured: Within 12 hours after taking medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start31 Jan 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence TrialStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TING LI, Second Affiliated Hospital of Wenzhou Medical University
- Investigators
- Ting Li, Master, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307132
- Sponsor's protocol ID
- SAHoWMU-CR2024-03-106
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Correlation of Drug Metabolism, Excretion, and Human Body Composition Based on the Bioequivalence Trial of Aximus Capsules
- ClinicalTrials.gov ID
- NCT06307132
- Acronym / sponsor ID
- SAHoWMU-CR2024-03-106
- Conditions
- Bioequivalence Trial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test preparation | – | Other: Aximus capsules（test） |
| reference preparation | – | Drug: Aximus capsules（reference） |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- Healthy adult men and non-pregnant non-lactating women who successfully participated in the bioequivalence test of acylimus capsules；
- 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.
Key exclusion criteria (2 listed)
- Female subjects who are menstruating (which may affect urine sample collection);
- The subjects may not be able to complete this study for other reasons or may not be suitable to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aximus capsules（test）Aximus capsules test preparation | Other | test preparation |
| Aximus capsules（reference）Aximus capsules reference preparation | Drug | reference preparation |
Primary outcome
Excretion volume
Time frame: Within 12 hours after taking medication
drug concentration in urine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Li, Master principal investigator
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bioequivalence Trial, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excretion volume (time frame: Within 12 hours after taking medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.