BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination.

Study Overview
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Brief Summary
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To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults.

Detailed Description
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To evaluate and compare Pharmacokinetics/Pharmacodynamics, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg in comparison to bilayer combination of Gemigliprin/Rosuvastatin 50/20mg administered in healthy volunteers

Official Title
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Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of the Monolayer Drug in Comparison to the Bilayer Drug Administered in Healthy Volunteers

Conditions
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Diabetes Mellitus, Type 2, Dyslipidemias

Intervention / Treatment
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* Drug: Monolayer group
* Drug: Bilayer group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 19 45 Body weight: 55kg or higher(female: 50kg or higher) and BMI 18 27kg/m2 SBP 90 150mmHg, DBP 60-95mmHg Fasting glucose 70 120mg/dL Infertility Surgically infertile To prevent pregnancy, participants who agreed using 2 or more contraceptive methods. Such as Barrier methods: Condom, Diaphragm, Cervical cap (Pessary), Spermicide Hormonal methods: Pills, Injection (Depot), Skin patch, Hormonal implant (Implanon), Vaginal ring Intrauterine Devices (IUDs): Cooper IUD (Loop), Hormonal IUD (Mirena) Natural methods: Basic body temperature, Ovulation period, Coitus interruptus, Abstinent People who perfectly understood clinical trial and independently decided to participate in clinical trial. People who will be able to collect blood sample during clinical trial period. People who are suitable to participate clinical trial by physical examination, lab test and medical examination by interview. Exclusion Criteria: Genetic problems such as galactose intolerance, Lapp lacatase deficiency, glucose-galactose malabsorption Clinically significant disease such as liver, kidney, digestive, pulmonary, endocrine system, cardiovascular disease etc. People who have gastrointestinal disease or history of surgery which would affect absorption of drug. History of clinically significant drug induced hyper-sensitive reaction or drug related muscular disease

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: monolayer group<br>monolayer of Gemigliptin/Rosuvastatin | Drug: Monolayer group<br>* Monolayered combination of gemigliptin and rosuvastatin<br>Drug: Bilayer group<br>* Bilayered combination of gemigliptin and rosuvastatin<br>|
| Experimental: bilayer group<br>bilayer of Gemigliptin/Rosuvastatin | Drug: Monolayer group<br>* Monolayered combination of gemigliptin and rosuvastatin<br>Drug: Bilayer group<br>* Bilayered combination of gemigliptin and rosuvastatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gemigliptin AUC | Gemigliptin | 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour | 
| Rosuvastain AUC | Rosuvastain | 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour | 
| Rosuvastain Cmax | Rosuvastain | 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour | 
| Gemigliptin Cmax | Gemigliptin | 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour |