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

NCT04544319 | Unknown Phase 1

• 1 other identifier: LG-GLCL002
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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

Conditions

T2DM

Outcome Measures

Primary Outcomes (17)

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Pre-dose (Day1 0 hour)

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 0.25hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 0.5hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 0.75hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 1hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 1.5hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 2hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 3hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 4hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 6hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 8hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 10hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 12hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 24hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 36hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 48hour

• Gemigliptin and dapagliflozin AUClast and Cmax

  each phase 17 times blood sampling, total 34 times blood sampling

  Day 1 72hour

Secondary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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

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

Drug: Zemiglo 50mg and Forxiga 10mg; Drug: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg

Interventions

Zemiglo 50mg and Forxiga 10mg DRUG

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

Also known as: zemiglo and Forxiga

Arm I; Arm II

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

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

Also known as: zemiglo and Forxiga

Arm I; Arm II

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• LG Chem: lead

MeSH Terms

Interventions

dapagliflozin

Study Officials

• seunghwan Lee

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

songyi park

CONTACT

02-6987-4195; songyi-park@lgchem.com

clinical LG Chem

CONTACT

lgclinical@lgchem.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: September 10, 2020
• Study Start: October 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share