Status:
UNKNOWN
BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination.
Lead Sponsor:
LG Chem
Conditions:
Diabetes Mellitus, Type 2
Dyslipidemias
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
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
To evaluate and compare Pharmacokinetics/Pharmacodynamics, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg in comparison to bilayer combination of Gemigliprin/Rosu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03867942
Start Date
March 21 2019
End Date
August 31 2019
Last Update
March 8 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.