BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone

A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of the Combination of Gemigliptin/Rosuvastatin 50/20 mg in Comparison to Each Component Gemigliptin 50 mg and Rosuvastatin 20 mg Administered in Healthy Male Volunteers

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02670070

Enrollment

Registered

2016-02-01

Start date

2016-03-31

Completion date

2016-06-30

Last updated

2016-05-11

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

Conditions

Healthy

Brief summary

This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

Detailed description

This study is to evaluate the safety/tolerability and pharmacokinetics(AUC and Cmax) of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

Interventions

DRUGgemigliptin 50mg, rosuvastatin 20mg

gemigliptin/rosuvastatin 50/20mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Age between 19 to 45, healthy male subjects(at screening) * BMI between 18.0 - 27.0 * FPG 70-125mg/dL glucose level(at screening) * Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion criteria

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.) * Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included) * Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics) * Subject who already participated in other trials in 2months * Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently. * Heavy smokers.(\>10 cigarettes per day)

Design outcomes

Primary

Measure	Time frame	Description
AUClast, Cmax	up to 72h post-dose	To evaluate AUClast/Cmax of gemigliptin and rosuvastatin

Secondary

Measure	Time frame	Description
Tmax	up to 72h post-dose	To evaluate Tmax of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
t1/2	up to 72h post-dose	To evaluate t1/2 of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
CL/F	up to 72h post-dose	To evaluate CL/F of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
AUCinf	up to 72h post-dose	To evaluate AUCinf of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
AUEC	up to 72h post-dose	This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.
Emax	up to 72h post-dose	This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.
metabolic ratio	up to 72h post-dose	To evaluate metabolic ratio of gemigliptin, LC15-0636 of gemigliptin metabolite

Countries

South Korea

Outcome results

None listed

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