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

Primary Purpose

Diabetes Mellitus, Type 2, Dyslipidemias

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Monolayer group

Bilayer group

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

monolayer group

bilayer group

Arm Description

monolayer of Gemigliptin/Rosuvastatin

bilayer of Gemigliptin/Rosuvastatin

Outcomes

Primary Outcome Measures

Gemigliptin AUC

Gemigliptin

Rosuvastain AUC

Rosuvastain

Rosuvastain Cmax

Rosuvastain

Gemigliptin Cmax

Gemigliptin

Secondary Outcome Measures

Full Information

NCT ID

NCT03867942

First Posted

March 6, 2019

Last Updated

March 6, 2019

Sponsor

LG Chem

1. Study Identification

Unique Protocol Identification Number

NCT03867942

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 21, 2019 (Anticipated)

Primary Completion Date

May 24, 2019 (Anticipated)

Study Completion Date

August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LG Chem

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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/Rosuvastatin 50/20mg administered in healthy volunteers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Dyslipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

monolayer group

Arm Type

Active Comparator

Arm Description

monolayer of Gemigliptin/Rosuvastatin

Arm Title

bilayer group

Arm Type

Experimental

Arm Description

bilayer of Gemigliptin/Rosuvastatin

Intervention Type

Drug

Intervention Name(s)

Monolayer group

Intervention Description

Monolayered combination of gemigliptin and rosuvastatin

Intervention Type

Drug

Intervention Name(s)

Bilayer group

Intervention Description

Bilayered combination of gemigliptin and rosuvastatin

Primary Outcome Measure Information:

Title

Gemigliptin AUC

Description

Gemigliptin

Time Frame

0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour

Title

Rosuvastain AUC

Description

Rosuvastain

Time Frame

0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour

Title

Rosuvastain Cmax

Description

Rosuvastain

Time Frame

0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour

Title

Gemigliptin Cmax

Description

Gemigliptin

Time Frame

0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

songyi Park

Phone

+82-2-6987-4195

songyi-park@lgchem.com

First Name & Middle Initial & Last Name or Official Title & Degree

hyejin Yoon

Phone

+82-2-6987-4155

lgclinical@lgchem.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

kyungsang Yoo

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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