Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04544319

Enrollment

Registered

2020-09-10

Start date

2020-10-31

Completion date

2021-07-31

Last updated

2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T2DM

Brief 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

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

Interventions

DRUGZemiglo 50mg and Forxiga 10mg

Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD

DRUGFixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg

Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy adults who are 19 years \ 50 years when they are screened 2. weight: 55.0 kg \ 90.0 kg and BMI: 18.0 kg/m2 \ 30.0 kg/m2 3. Volunteers who understand the procedures of clinical trial and signed informed consent form 4. Volunteers who are eligible decided by vital signs, physical examination, lab test and 12-lead ECG 5. Women of chlidbearing potential have negative results in pregnancy test

Exclusion criteria

1. Healtjy volunteers who don't have clinically significant disease such as liver disease, severe renal disease, acute pancreatitis... etc 2. Drug Allergy in aspirin, NSAID, Anti-bacterial drugs 3. GI tract diseases which affect PK results and safety such as ulceritis, GERD, chron disease... 4. Chronic urine track infection 5. Allergy history in sunset yellow 5 pigment and Fast green FCF (pigment) 6. galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption 7. 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% 8. SBP\<90mmHg or \>150mmHg, DBP \<60mmHg or \>100mmHg

Design outcomes

Primary

Measure	Time frame	Description
Gemigliptin and dapagliflozin AUClast and Cmax	Pre-dose (Day1 0 hour)	each phase 17 times blood sampling, total 34 times blood sampling

Secondary

Measure	Time frame	Description
Gemigliptin and dapagliflozin V/F	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin AUCinf	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin Tmax	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin t1/2	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin and dapagliflozin CL/F	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin metabolite(LC15-0636) Cmax	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin metabolite(LC15-0636) AUCinf	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin metabolite(LC15-0636) t1/2	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin metabolite(LC15-0636) metabolic ratio	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	each phase 17 times blood sampling, total 34 times blood sampling
Gemigliptin metabolite(LC15-0636) AUClast	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	each phase 17 times blood sampling, total 34 times blood sampling

Contacts

Primary Contactsongyi park

songyi-park@lgchem.com02-6987-4195

Backup Contactclinical LG Chem

lgclinical@lgchem.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026