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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-21

Study Completion Date

2019-08-31

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.

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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

Conditions

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Diabetes Mellitus, Type 2 Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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monolayer group

monolayer of Gemigliptin/Rosuvastatin

Group Type ACTIVE_COMPARATOR

Monolayer group

Intervention Type DRUG

Monolayered combination of gemigliptin and rosuvastatin

Bilayer group

Intervention Type DRUG

Bilayered combination of gemigliptin and rosuvastatin

bilayer group

bilayer of Gemigliptin/Rosuvastatin

Group Type EXPERIMENTAL

Monolayer group

Intervention Type DRUG

Monolayered combination of gemigliptin and rosuvastatin

Bilayer group

Intervention Type DRUG

Bilayered combination of gemigliptin and rosuvastatin

Interventions

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Monolayer group

Monolayered combination of gemigliptin and rosuvastatin

Intervention Type DRUG

Bilayer group

Bilayered combination of gemigliptin and rosuvastatin

Intervention Type DRUG

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

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes