Clinical trial NCT04544319: Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: T2DM
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Pre-dose (Day1 0 hour)
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 0.25hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 0.5hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 0.75hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 1hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 1.5hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 2hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 3hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 4hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 6hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 8hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 10hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 12hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 24hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 36hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 48hour
measure: Gemigliptin and dapagliflozin AUClast and Cmax
timeFrame: Day 1 72hour
Secondary outcomes:
measure: Gemigliptin and dapagliflozin AUCinf
timeFrame: 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
measure: Gemigliptin and dapagliflozin Tmax
timeFrame: 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
measure: Gemigliptin and dapagliflozin t1/2
timeFrame: 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
measure: Gemigliptin and dapagliflozin CL/F
timeFrame: 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
measure: Gemigliptin and dapagliflozin V/F
timeFrame: 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
measure: Gemigliptin metabolite(LC15-0636) AUClast
timeFrame: 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
measure: Gemigliptin metabolite(LC15-0636) Cmax
timeFrame: 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
measure: Gemigliptin metabolite(LC15-0636) AUCinf
timeFrame: 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
measure: Gemigliptin metabolite(LC15-0636) t1/2
timeFrame: 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
measure: Gemigliptin metabolite(LC15-0636) metabolic ratio
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: seunghwan Lee
role: PRINCIPAL_INVESTIGATOR
References: