T2DMPhase 1NCT04544319
Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg
A Phase 1 study testing Zemiglo 50mg and Forxiga 10mg and Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg in people with T2DM, run by LG Chem.
Trial summary
To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- T2DM
- What is being tested?
- Zemiglo 50mg and Forxiga 10mg and Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Jul 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults who are 19 years ~ 50 years when they are screened
- weight: 55.0 kg ~ 90.0 kg and BMI: 18.0 kg/m2 ~ 30.0 kg/m2
- Volunteers who understand the procedures of clinical trial and signed informed consent form
- Volunteers who are eligible decided by vital signs, physical examination, lab test and 12-lead ECG
- Women of chlidbearing potential have negative results in pregnancy test
Who cannot join
- Healtjy volunteers who don't have clinically significant disease such as liver disease, severe renal disease, acute pancreatitis... etc
- Drug Allergy in aspirin, NSAID, Anti-bacterial drugs
- GI tract diseases which affect PK results and safety such as ulceritis, GERD, chron disease...
- Chronic urine track infection
- Allergy history in sunset yellow 5 pigment and Fast green FCF (pigment)
- galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
Show all 14Show fewer
- These resluts are appeared when screening
- ALT, AST >= 1.5 Upper limit of normal range
- HbsAg, anti-HCV, HIV Ag\&Ab positive
- MDRD equation: eGFR< 60 mL/min/1.73m2
- QTcB> 450 ms
- Fasting serum glucose < 70mg/dL or >110mg/dL
- HbA1c>6.5%
- SBP<90mmHg or >150mmHg, DBP <60mmHg or >100mmHg
Trial locations and contacts
No sites are listed yet.
clinical LG Chem contact
About this study
Official title: Clinical Trial to Compare the Pharmacokinetics, Safety and Tolerability of the FDC of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg
To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg
Read the detailed description
To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg Also we identify safety and tolerance of FDC and each component
- Conditions
- T2DM
- Being tested
- Zemiglo 50mg and Forxiga 10mg, Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zemiglo 50mg and Forxiga 10mgDrug
Also called zemiglo and Forxiga
Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD
Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mgDrug
Also called zemiglo and Forxiga
Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg Receives: Drug: Zemiglo 50mg and Forxiga 10mg; Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg |
| Arm II | Experimental | Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg Receives: Drug: Zemiglo 50mg and Forxiga 10mg; Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Pre-dose (Day1 0 hour)
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 0.25hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 0.5hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 0.75hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 1hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 1.5hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 2hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 3hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 4hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 6hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 8hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 10hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 12hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 24hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 36hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 48hour
Gemigliptin and dapagliflozin AUClast and Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Day 1 72hour
Secondary outcomes (10)
Gemigliptin and dapagliflozin AUCinf
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin Tmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin t1/2
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin CL/F
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin V/F
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) AUClast
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) Cmax
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Pre-dose (Day1 0 h), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) AUCinf
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) t1/2
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) metabolic ratio
each phase 17 times blood sampling, total 34 times blood sampling
Measured: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DMStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- seunghwan Lee, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544319
- Sponsor's protocol ID
- LG-GLCL002
- Status last verified
- Sep 2020
- First submitted
- 29 Jul 2020
- Last updated
- 11 Sep 2020
- 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 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Compare the Pharmacokinetics, Safety and Tolerability of the FDC of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg
- ClinicalTrials.gov ID
- NCT04544319
- Acronym / sponsor ID
- LG-GLCL002
- Conditions
- T2DM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- Oct 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 10 Sep 2020 (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 identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg
Detailed description
To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg Also we identify safety and tolerance of FDC and each component
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Zemiglo 50mg and Forxiga 10mg, Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mgFirstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg |
| Arm II | Experimental | Drug: Zemiglo 50mg and Forxiga 10mg, Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mgFirstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults who are 19 years ~ 50 years when they are screened
- weight: 55.0 kg ~ 90.0 kg and BMI: 18.0 kg/m2 ~ 30.0 kg/m2
- Volunteers who understand the procedures of clinical trial and signed informed consent form
- Volunteers who are eligible decided by vital signs, physical examination, lab test and 12-lead ECG
- Women of chlidbearing potential have negative results in pregnancy test
Key exclusion criteria (14 listed)
- Healtjy volunteers who don't have clinically significant disease such as liver disease, severe renal disease, acute pancreatitis... etc
- Drug Allergy in aspirin, NSAID, Anti-bacterial drugs
- GI tract diseases which affect PK results and safety such as ulceritis, GERD, chron disease...
- Chronic urine track infection
- Allergy history in sunset yellow 5 pigment and Fast green FCF (pigment)
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 |
|---|---|---|
| Zemiglo 50mg and Forxiga 10mgAlso: zemiglo and ForxigaEach component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD | Drug | Arm I, Arm II |
| Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mgAlso: zemiglo and ForxigaFixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD | Drug | Arm I, Arm II |
Primary outcome
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Pre-dose (Day1 0 hour)
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 0.25hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 0.5hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 0.75hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 1hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 1.5hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 2hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 3hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 4hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 6hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 8hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 10hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 12hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 24hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 36hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 48hour
each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUClast and Cmax
Time frame: Day 1 72hour
each phase 17 times blood sampling, total 34 times blood sampling
10 secondary outcomes
Gemigliptin and dapagliflozin AUCinf
Time frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin Tmax
Time frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin t1/2
Time frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin CL/F
Time frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin and dapagliflozin V/F
Time frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) AUClast
Time frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) Cmax
Time frame: Pre-dose (Day1 0 h), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) AUCinf
Time frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) t1/2
Time frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Gemigliptin metabolite(LC15-0636) metabolic ratio
Time frame: Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- 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.
clinical LG Chem contact
seunghwan Lee principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zemiglo 50mg and Forxiga 10mg and Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg in people with T2DM, 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 5 inclusion and 14 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 Sep 2020. 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 (02-6987-4195, 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 and dapagliflozin AUClast and Cmax (time frame: Pre-dose (Day1 0 hour)). The study lists 17 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 11 Sep 2020.