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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03867942

Enrollment

Registered

2019-03-08

Start date

2019-03-21

Completion date

2019-08-31

Last updated

2019-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Dyslipidemias

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

Interventions

DRUGMonolayer group

Monolayered combination of gemigliptin and rosuvastatin

DRUGBilayer group

Bilayered combination of gemigliptin and rosuvastatin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Contacts

Primary Contactsongyi Park

songyi-park@lgchem.com+82-2-6987-4195

Backup Contacthyejin Yoon

lgclinical@lgchem.com+82-2-6987-4155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026