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

LG Chem

Status and phase: Unknown; Phase 1

Conditions: Dyslipidemias; Diabetes Mellitus, Type 2

Treatments: Drug: Monolayer group; Drug: Bilayer group

Study type: Interventional

Funder types: Industry

Identifiers

NCT03867942

LG-GSCL006

Details and patient eligibility

About

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.

Full 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/Rosuvastatin 50/20mg administered in healthy volunteers

Enrollment: 48 estimated patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

monolayer group

Active Comparator group

Description:

monolayer of Gemigliptin/Rosuvastatin

Treatment:

Drug: Monolayer group

Drug: Bilayer group

bilayer group

Experimental group

Description:

bilayer of Gemigliptin/Rosuvastatin

Treatment:

Drug: Monolayer group

Drug: Bilayer group