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
Overview
- Phase
- Phase 1
- Intervention
- Zemiglo 50mg and Forxiga 10mg
- Conditions
- T2DM
- Sponsor
- LG Chem
- Enrollment
- 44
- Primary Endpoint
- Gemigliptin and dapagliflozin AUClast and Cmax
- Last Updated
- 5 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Arm I
Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
Intervention: Zemiglo 50mg and Forxiga 10mg
Arm I
Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
Intervention: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
Arm II
Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg
Intervention: Zemiglo 50mg and Forxiga 10mg
Arm II
Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg
Intervention: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
Outcomes
Primary Outcomes
Gemigliptin and dapagliflozin AUClast and Cmax
Time Frame: Day 1 72hour
each phase 17 times blood sampling, total 34 times blood sampling
Secondary Outcomes
- 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 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)
- 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)
- 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 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)
- 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 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)
- 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 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)
- 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)