Diabetes Mellitus, Type 2Phase 1NCT03867942
BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination.
A Phase 1 study testing Monolayer group and Bilayer group in people with Diabetes Mellitus, Type 2 and Dyslipidemias, run by LG Chem.
Trial summary
To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Dyslipidemias
- What is being tested?
- Monolayer group and Bilayer group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2019to 31 Aug 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 19~45
- Body weight: 55kg or higher(female: 50kg or higher) and BMI 18~27kg/m2
- SBP 90~150mmHg, DBP 60-95mmHg
- Fasting glucose 70~120mg/dL
- Infertility
- Surgically infertile
Show all 14Show fewer
- To prevent pregnancy, participants who agreed using 2 or more contraceptive methods. Such as
- Barrier methods: Condom, Diaphragm, Cervical cap (Pessary), Spermicide
- Hormonal methods: Pills, Injection (Depot), Skin patch, Hormonal implant (Implanon), Vaginal ring
- Intrauterine Devices (IUDs): Cooper IUD (Loop), Hormonal IUD (Mirena)
- Natural methods: Basic body temperature, Ovulation period, Coitus interruptus, Abstinent
- People who perfectly understood clinical trial and independently decided to participate in clinical trial.
- People who will be able to collect blood sample during clinical trial period.
- People who are suitable to participate clinical trial by physical examination, lab test and medical examination by interview.
Who cannot join
- Genetic problems such as galactose intolerance, Lapp lacatase deficiency, glucose-galactose malabsorption
- Clinically significant disease such as liver, kidney, digestive, pulmonary, endocrine system, cardiovascular disease etc.
- People who have gastrointestinal disease or history of surgery which would affect absorption of drug.
- History of clinically significant drug induced hyper-sensitive reaction or drug related muscular disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of the Monolayer Drug in Comparison to the Bilayer Drug Administered in Healthy Volunteers
To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults.
Read the detailed description
To evaluate and compare Pharmacokinetics/Pharmacodynamics, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg in comparison to bilayer combination of Gemigliprin/Rosuvastatin 50/20mg administered in healthy volunteers
- Conditions
- Diabetes Mellitus, Type 2, Dyslipidemias
- Being tested
- Monolayer group, Bilayer group
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monolayer groupDrug
Monolayered combination of gemigliptin and rosuvastatin
Bilayer groupDrug
Bilayered combination of gemigliptin and rosuvastatin
| Study group | Role | What they receive |
|---|---|---|
| monolayer group | Active comparator | monolayer of Gemigliptin/Rosuvastatin Receives: Drug: Monolayer group; Drug: Bilayer group |
| bilayer group | Experimental | bilayer of Gemigliptin/Rosuvastatin Receives: Drug: Monolayer group; Drug: Bilayer group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gemigliptin AUC
Gemigliptin
Measured: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Rosuvastain AUC
Rosuvastain
Measured: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Rosuvastain Cmax
Rosuvastain
Measured: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Gemigliptin Cmax
Gemigliptin
Measured: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start21 Mar 2019 (estimated)
- Primary completion24 May 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- kyungsang Yoo, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867942
- Sponsor's protocol ID
- LG-GSCL006
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 8 Mar 2019
- 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 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of the Monolayer Drug in Comparison to the Bilayer Drug Administered in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03867942
- Acronym / sponsor ID
- LG-GSCL006
- Conditions
- Diabetes Mellitus, Type 2, Dyslipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2019 (estimated)
- Primary completion
- 24 May 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 8 Mar 2019 (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.
To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults.
Detailed description
To evaluate and compare Pharmacokinetics/Pharmacodynamics, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg in comparison to bilayer combination of Gemigliprin/Rosuvastatin 50/20mg administered in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monolayer group | Active comparator | Drug: Monolayer group, Drug: Bilayer groupmonolayer of Gemigliptin/Rosuvastatin |
| bilayer group | Experimental | Drug: Monolayer group, Drug: Bilayer groupbilayer of Gemigliptin/Rosuvastatin |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age: 19~45
- Body weight: 55kg or higher(female: 50kg or higher) and BMI 18~27kg/m2
- SBP 90~150mmHg, DBP 60-95mmHg
- Fasting glucose 70~120mg/dL
- Infertility
Key exclusion criteria (4 listed)
- Genetic problems such as galactose intolerance, Lapp lacatase deficiency, glucose-galactose malabsorption
- Clinically significant disease such as liver, kidney, digestive, pulmonary, endocrine system, cardiovascular disease etc.
- People who have gastrointestinal disease or history of surgery which would affect absorption of drug.
- History of clinically significant drug induced hyper-sensitive reaction or drug related muscular disease
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 |
|---|---|---|
| Monolayer groupMonolayered combination of gemigliptin and rosuvastatin | Drug | bilayer group, monolayer group |
| Bilayer groupBilayered combination of gemigliptin and rosuvastatin | Drug | bilayer group, monolayer group |
Primary outcome
Gemigliptin AUC
Time frame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Gemigliptin
Rosuvastain AUC
Time frame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Rosuvastain
Rosuvastain Cmax
Time frame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Rosuvastain
Gemigliptin Cmax
Time frame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Gemigliptin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- 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.
kyungsang Yoo principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Monolayer group and Bilayer group in people with Diabetes Mellitus, Type 2 and Dyslipidemias, run by LG Chem.
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 14 inclusion and 4 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 8 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact songyi Park (+82-2-6987-4195, songyi-park@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gemigliptin AUC (time frame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour). The study lists 4 primary outcomes in all. 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 8 Mar 2019.