HealthyPhase 1NCT02670070
BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone
A Phase 1 study testing gemigliptin 50mg, rosuvastatin 20mg in people with Healthy, run by LG Life Sciences at 1 site in South Korea.
Trial summary
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- gemigliptin 50mg, rosuvastatin 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Jun 2016
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 19 to 45, healthy male subjects(at screening)
- BMI between 18.0 - 27.0
- FPG 70-125mg/dL glucose level(at screening)
- Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Who cannot join
- Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
- Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
- Subject who already participated in other trials in 2months
- Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.
- Heavy smokers.(>10 cigarettes per day)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of the Combination of Gemigliptin/Rosuvastatin 50/20 mg in Comparison to Each Component Gemigliptin 50 mg and Rosuvastatin 20 mg Administered in Healthy Male Volunteers
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.
Read the detailed description
This study is to evaluate the safety/tolerability and pharmacokinetics(AUC and Cmax) of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- gemigliptin 50mg, rosuvastatin 20mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemigliptin 50mg, rosuvastatin 20mgDrug
Also called Zemiglo, Cresto
gemigliptin/rosuvastatin 50/20mg
| Study group | Role | What they receive |
|---|---|---|
| Coadministration of G+R | Active comparator | Coadministration of gemigliptin 50mg and rosuvastatin 20mg Receives: Drug: gemigliptin 50mg, rosuvastatin 20mg |
| Combination G/R | Experimental | Combination of gemigliptin 50mg / rosuvastatin 20mg Receives: Drug: gemigliptin 50mg, rosuvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast, Cmax
To evaluate AUClast/Cmax of gemigliptin and rosuvastatin
Measured: up to 72h post-dose
Secondary outcomes (7)
AUCinf
To evaluate AUCinf of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
Measured: up to 72h post-dose
Tmax
To evaluate Tmax of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
Measured: up to 72h post-dose
t1/2
To evaluate t1/2 of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
Measured: up to 72h post-dose
CL/F
To evaluate CL/F of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
Measured: up to 72h post-dose
metabolic ratio
To evaluate metabolic ratio of gemigliptin, LC15-0636 of gemigliptin metabolite
Measured: up to 72h post-dose
AUEC
This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.
Measured: up to 72h post-dose
Emax
This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.
Measured: up to 72h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung Sang Yu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670070
- Sponsor's protocol ID
- LG-GSCL003
- Status last verified
- Jan 2016
- First submitted
- 22 Dec 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of the Combination of Gemigliptin/Rosuvastatin 50/20 mg in Comparison to Each Component Gemigliptin 50 mg and Rosuvastatin 20 mg Administered in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02670070
- Acronym / sponsor ID
- LG-GSCL003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 1 Feb 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.
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.
Detailed description
This study is to evaluate the safety/tolerability and pharmacokinetics(AUC and Cmax) of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coadministration of G+R | Active comparator | Drug: gemigliptin 50mg, rosuvastatin 20mgCoadministration of gemigliptin 50mg and rosuvastatin 20mg |
| Combination G/R | Experimental | Drug: gemigliptin 50mg, rosuvastatin 20mgCombination of gemigliptin 50mg / rosuvastatin 20mg |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 19 to 45, healthy male subjects(at screening)
- BMI between 18.0 - 27.0
- FPG 70-125mg/dL glucose level(at screening)
- Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Key exclusion criteria (6 listed)
- Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
- Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
- Subject who already participated in other trials in 2months
- Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.
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 |
|---|---|---|
| gemigliptin 50mg, rosuvastatin 20mgAlso: Zemiglo, Crestogemigliptin/rosuvastatin 50/20mg | Drug | Coadministration of G+R, Combination G/R |
Primary outcome
AUClast, Cmax
Time frame: up to 72h post-dose
To evaluate AUClast/Cmax of gemigliptin and rosuvastatin
7 secondary outcomes
AUCinf
Time frame: up to 72h post-dose
Tmax
Time frame: up to 72h post-dose
t1/2
Time frame: up to 72h post-dose
CL/F
Time frame: up to 72h post-dose
metabolic ratio
Time frame: up to 72h post-dose
AUEC
Time frame: up to 72h post-dose
Emax
Time frame: up to 72h post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Individual participant dataSharing planned: No
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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.
Kyung Sang Yu, MD, PhD principal investigator
Seoul National University Hospital
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 gemigliptin 50mg, rosuvastatin 20mg in people with Healthy, run by LG Life Sciences 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 4 inclusion and 6 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 11 May 2016. 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?
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?
AUClast, Cmax (time frame: up to 72h post-dose). 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 11 May 2016.