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

• Status: Unknown status
• Trial end date: 2019-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LG Chem
• Treatments: Rosuvastatin Calcium

Criteria

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

1. Surgically infertile

2. 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