Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male Subjects

A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Gemigliptin and Glimepiride in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01768455

Enrollment

Registered

2013-01-15

Start date

2013-02-28

Completion date

Unknown

Last updated

2013-04-23

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

Conditions

Healthy

Brief summary

The objective of the study was to investigate the pharmacokinetic drug interaction between gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly and each alone.

Interventions

DRUGGemigliptin and Glimepiride

Gemigliptin 50mg (qd) on Day1\ Day6 and Gemigliptin 50mg (qd) and Glimepiride 4mg (qd) on Day7

DRUGGlimepiride

Glimepiride 4mg (qd) on Day1

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Age between 20 to 45, healthy male subjects (at screening) * BMI between 18 - 27 (at screening) * 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

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.(gemigliptin, glimepiride, aspirin, antibiotics) * Subject who already participated in other trials in 90 days * Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently

Design outcomes

Primary

Measure	Time frame	Description
AUC	up to 24h post-dose	To evaluate AUCτ,ss of gemigliptin and AUClast of glimepiride
Cmax	up to 24h post-dose	To evaluate Cmax,ss of gemigliptin and Cmax of glimepiride

Secondary

Measure	Time frame	Description
Tmax	up to 24h post-dose	To evaluate Tmax,ss of gemigliptin/LC15-0636 and Tmax of glimepiride/M1
t1/2β	up to 24h post-dose	To evaluate t1/2β of gemigliptin/LC15-0636/glimepiride/M1
AUC	up to 24h post-dose	To evaluate AUCτ,ss of LC15-0636 and AUClast of M1
Cmax	up to 24h post-dose	To evaluate Cmax,ss of LC15-0636 and Cmax of M1

Countries

South Korea

Outcome results

None listed

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