HealthyPhase 1NCT02712619
Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers
A Phase 1 study testing Metformin in people with Healthy, run by Seoul National University Hospital.
Trial summary
Two doses of metformin with 12 hour interval low dose group (375/250 mg) high dose group (1000/1000mg) Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Sep 2014
- Phase
- Phase 1
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20 to 45
- Body weight 50 to 100 kg
- fasting serum glucose 70 to 125 mg/dL
- who provide informed consent voluntarily
Who cannot join
- any significant renal, gastrointestinal, hepatic, and metabolic condition
- any co/prior medication within 14 days of study drug administration
About this study
Official title: An Open-label, Parallel Group Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of 250/1000 mg of Metformin IR After Oral Administration in Healthy Male Volunteers
Two doses of metformin with 12 hour interval
- low dose group (375/250 mg)
- high dose group (1000/1000mg)
Read the detailed description
A study to evaluate and compare the pharmacokinetic-pharmacodynamic relationship between different metformin dose groups.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| metformin 250mg | Experimental | metformin 375/250 mg Receives: Drug: Metformin |
| metformin 1000mg | Experimental | metformin 1000/1000 mg Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration
Measured: 0-12 hour
Area under the metformin concentration curve
Measured: 0-12 hour
Area under the glucose curve
Measured: 2-5 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startMay 2014
- Primary completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Yong Chung, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712619
- Sponsor's protocol ID
- MP0
- Status last verified
- Mar 2016
- First submitted
- 22 Feb 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
Publications
Chung H, Oh J, Yoon SH, Yu KS, Cho JY, Chung JY. A non-linear pharmacokinetic-pharmacodynamic relationship of metformin in healthy volunteers: An open-label, parallel group, randomized clinical study. PLoS One. 2018 Jan 17;13(1):e0191258. doi: 10.1371/journal.pone.0191258. eCollection 2018.
PubMed 29342199
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel Group Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of 250/1000 mg of Metformin IR After Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02712619
- Acronym / sponsor ID
- MP0
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- First posted
- 18 Mar 2016 (estimated)
- 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.
Two doses of metformin with 12 hour interval
- low dose group (375/250 mg)
- high dose group (1000/1000mg)
Detailed description
A study to evaluate and compare the pharmacokinetic-pharmacodynamic relationship between different metformin dose groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin 250mg | Experimental | Drug: Metforminmetformin 375/250 mg |
| metformin 1000mg | Experimental | Drug: Metforminmetformin 1000/1000 mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20 to 45
- Body weight 50 to 100 kg
- fasting serum glucose 70 to 125 mg/dL
- who provide informed consent voluntarily
Key exclusion criteria (2 listed)
- any significant renal, gastrointestinal, hepatic, and metabolic condition
- any co/prior medication within 14 days of study drug administration
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 |
|---|---|---|
| Metformin | Drug | metformin 1000mg, metformin 250mg |
Primary outcome
Maximum plasma concentration
Time frame: 0-12 hour
Area under the metformin concentration curve
Time frame: 0-12 hour
Area under the glucose curve
Time frame: 2-5 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Derived from this study: PubMed 29342199Chung H, Oh J, Yoon SH, Yu KS, Cho JY, Chung JY. A non-linear pharmacokinetic-pharmacodynamic relationship of metformin in healthy volunteers: An open-label, parallel group, randomized clinical study. PLoS One. 2018 Jan 17;13(1):e0191258. doi: 10.1371/journal.pone.0191258. eCollection 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin in people with Healthy, run by Seoul National University Hospital.
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 4 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: finished, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum plasma concentration (time frame: 0-12 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712619, which also lists 1 linked publication.
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 18 Mar 2016.