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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01768455
First received: January 13, 2013
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Gemigliptin and Glimepiride
Drug: Glimepiride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Gemigliptin and Glimepiride in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • AUC [ Time Frame: up to 24h post-dose ] [ Designated as safety issue: No ]
    To evaluate AUCτ,ss of gemigliptin and AUClast of glimepiride

  • Cmax [ Time Frame: up to 24h post-dose ] [ Designated as safety issue: No ]
    To evaluate Cmax,ss of gemigliptin and Cmax of glimepiride


Secondary Outcome Measures:
  • Tmax [ Time Frame: up to 24h post-dose ] [ Designated as safety issue: No ]
    To evaluate Tmax,ss of gemigliptin/LC15-0636 and Tmax of glimepiride/M1

  • t1/2β [ Time Frame: up to 24h post-dose ] [ Designated as safety issue: No ]
    To evaluate t1/2β of gemigliptin/LC15-0636/glimepiride/M1

  • AUC [ Time Frame: up to 24h post-dose ] [ Designated as safety issue: No ]
    To evaluate AUCτ,ss of LC15-0636 and AUClast of M1

  • Cmax [ Time Frame: up to 24h post-dose ] [ Designated as safety issue: No ]
    To evaluate Cmax,ss of LC15-0636 and Cmax of M1


Enrollment: 27
Study Start Date: February 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768455

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
Investigators
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01768455     History of Changes
Other Study ID Numbers: LG-DPCL013
Study First Received: January 13, 2013
Last Updated: April 22, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Glimepiride
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 14, 2014