HyperlipidemiaPhase 1NCT02186483
Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin
A Phase 1 study testing Metformin, Rosuvastatin and Metformin and Rosuvastatin in people with Hyperlipidemia and Diabetes, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Diabetes
- What is being tested?
- Metformin, Rosuvastatin and Metformin and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Feb 2015
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19~55 years healthy male
- BMI measurement 19.0kg/m^2~ 28.0kg/m^2
- Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
Who cannot join
- History of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
- SBP>140mmHg or <90mmHg, DBP>90mmHg or <60mmHg.
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
- History of drug abuse
- A alcohol consumer(alcohol>140g/week) or smoker(cigarette>10 cigarettes/day) Hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics)
- Administrated investigational product in a previous clinical trial within 60 days of the screening day in this study.
Show all 9Show fewer
- Administrated drugs which can inhibit or induce OCT2, OATP1B1 transporter within 30 days of the screening day in this study.(ex: proton pump inhibitor, rifampicin)
- Glomerular filtration rate<60mL/min
- Donated blood within 60 days prior to the screening day or apheresis blood within 30 days prior to the screening day .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Following Coadministration of Metformin and Rosuvastatin in Healthy Male Volunteers
The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.
Read the detailed description
Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy Male Volunteers
- Conditions
- Hyperlipidemia, Diabetes
- Being tested
- Metformin, Rosuvastatin, Metformin and Rosuvastatin
- Medical subject headings
- Hyperlipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucodown OR SR tablet
Metformin,1000mg, once daily
RosuvastatinDrug
Also called Crestor tablet
Rosuvastatin, 20 mg, once daily
Metformin and RosuvastatinDrug
Also called Glucodown OR SR tablet and Crestor tablet
Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration Receives: Drug: Metformin; Drug: Rosuvastatin; Drug: Metformin and Rosuvastatin |
| Rosuvastatin | Experimental | Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin Receives: Drug: Metformin; Drug: Rosuvastatin; Drug: Metformin and Rosuvastatin |
| Co-administration | Experimental | Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin Receives: Drug: Metformin; Drug: Rosuvastatin; Drug: Metformin and Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss, AUCτ
Measured: 32h
Secondary outcomes (5)
Tmax,ss
Measured: 32h
t1/2
Measured: 32h
Cmin,ss
Measured: 32h
CL/Fss
Measured: 32h
Vd/Fss
Measured: 32h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jung-ryul Kim, MD, Ph.D, Principal investigator, Samsung Medical Center(SMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186483
- Sponsor's protocol ID
- JLP_1310-P1-DI
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Following Coadministration of Metformin and Rosuvastatin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02186483
- Acronym / sponsor ID
- JLP_1310-P1-DI
- Conditions
- Hyperlipidemia, Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Jul 2014 (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.
The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.
Detailed description
Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy Male Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin, Drug: Rosuvastatin, Drug: Metformin and RosuvastatinMetformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration |
| Rosuvastatin | Experimental | Drug: Metformin, Drug: Rosuvastatin, Drug: Metformin and RosuvastatinMetformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin |
| Co-administration | Experimental | Drug: Metformin, Drug: Rosuvastatin, Drug: Metformin and RosuvastatinMetformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 19~55 years healthy male
- BMI measurement 19.0kg/m^2~ 28.0kg/m^2
- Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
Key exclusion criteria (9 listed)
- History of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
- SBP>140mmHg or <90mmHg, DBP>90mmHg or <60mmHg.
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
- History of drug abuse
- A alcohol consumer(alcohol>140g/week) or smoker(cigarette>10 cigarettes/day) Hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics)
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 |
|---|---|---|
| MetforminAlso: Glucodown OR SR tabletMetformin,1000mg, once daily | Drug | Co-administration, Metformin, Rosuvastatin |
| RosuvastatinAlso: Crestor tabletRosuvastatin, 20 mg, once daily | Drug | Co-administration, Metformin, Rosuvastatin |
| Metformin and RosuvastatinAlso: Glucodown OR SR tablet and Crestor tabletMetformin, 1000mg, once daily Rosuvastatin, 20mg, once daily | Drug | Co-administration, Metformin, Rosuvastatin |
Primary outcome
Cmax,ss, AUCτ
Time frame: 32h
5 secondary outcomes
Tmax,ss
Time frame: 32h
t1/2
Time frame: 32h
Cmin,ss
Time frame: 32h
CL/Fss
Time frame: 32h
Vd/Fss
Time frame: 32h
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 29 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Hyperlipidemia
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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.
Jung-ryul Kim, MD, Ph.D principal investigator
Samsung Medical Center(SMC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin, Rosuvastatin and Metformin and Rosuvastatin in people with Hyperlipidemia and Diabetes, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 3 inclusion and 9 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 29 Mar 2018. 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 South Korea. 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.
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?
Cmax,ss, AUCτ (time frame: 32h). 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 29 Mar 2018.