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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Gemigliptin and Glimepiride; Drug: Glimepiride

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gemigliptin and Glimepiride; Multiple administrations of gemigliptin and single concomitant administration of gemigliptin and glimepiride	Drug: Gemigliptin and Glimepiride; Gemigliptin 50mg (qd) on Day1~Day6 and Gemigliptin 50mg (qd) and Glimepiride 4mg (qd) on Day7
Experimental: Glimepiride; Single administration of glimepiride	Drug: Glimepiride; Glimepiride 4mg (qd) on Day1

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LG Life Sciences

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 13, 2013
• First Submitted That Met QC Criteria: January 14, 2013
• First Posted (Estimate): January 15, 2013

Study Record Updates

• Last Update Posted (Estimate): April 23, 2013
• Last Update Submitted That Met QC Criteria: April 22, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Glimepiride
• Other Study ID Numbers: LG-DPCL013