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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03867942
• Other study ID #: LG-GSCL006
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 21, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: March 2019
• Source: LG Chem
• Contact: songyi Park
• Phone: +82-2-6987-4195
• Email: songyi-park[@]lgchem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: August 31, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemias

Intervention

Drug:
• Monolayer group
Monolayered combination of gemigliptin and rosuvastatin
• Bilayer group
Bilayered combination of gemigliptin and rosuvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gemigliptin AUC	Gemigliptin	0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Primary	Rosuvastain AUC	Rosuvastain	0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Primary	Rosuvastain Cmax	Rosuvastain	0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Primary	Gemigliptin Cmax	Gemigliptin	0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour