Fed Conditions, Healthy Volunteer
Conditions
Keywords
Bioequivalence study, Fed condition
Brief summary
Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers
Interventions
DRUGTest drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg
All participants take 1 tablet of either test drug or reference drug after meal.
DRUGReference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg
All participants take 1 tablet of either test drug or reference drug after meal.
Sponsors
LG Chem
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. Age 19-50 years in healthy volunteers 2. 18.0 kg/m\^2 ≤ BMI ≤ 29.9 kg/m\^2, 50kg ≤weight ≤ 90kg 3. 60≤ FPG≤125 mg/dL 4. Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial.
Exclusion criteria
1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system. 2. Subjects with clinically significant abnormal findings during tests (or examinations) 3. Subjects with a history of hypersensitivity or clinically significant hypersensitivity reactions to test drugs or other drugs 4. Subjects judged ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The plasma concentration of gemigliptin, dapagliflozin, and metformin | - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration | Primary Parameters: Area under the plasma concentration versus time curve (AUClast) of gemigliptin, dapagliflozin, and metformin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The plasma concentration of gemigliptin, dapagliflozin and metformin | Period 1: 16 times up to 72 hours from IP administration Period 2: 16 times up to 72 hours from IP administration | Secondary Parameters: Time to Maximum(Tmax) Concentration of gemigliptin, dapagliflozin, and metformin |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment - Safety (Vital sign) | 7 times until 72 hours from IP administration | Systolic Blood Pressure(mmHg), Diastolic Blood Pressure(mmHg), Pulse Rate(beats/min), Temperature(℃) |
| Assessment - Safety (Adverse events) | up to day 18 (post study visit) | A list of all adverse events for each treatment group and for all participants with seriousness, severity, relationship with investigational product. A number of participant with adverse event. |
| Assessment - Safety (Clinical laboratory test results) | 4 times until post-study visit | Hematology, Blood Chemistry, Urinalysis |
| Assessment - Safety (12-lead ECG results) | 4 times until post-study visit | Ventricular rate(beats/min), PR interval(msec), QRS(msec), QT(msec), QTcB(msec) |
| Assessment - Safety (Physical examination) | 3 times until 72 hours from IP administration | Any finding in general condition, nutritional status and other category by medical interview |
Countries
South Korea
Outcome results
None listed