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

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ClinicalTrials.gov Identifier: NCT01768455
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Gemigliptin and Glimepiride Drug: Glimepiride Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2013
Actual Primary Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Glimepiride

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




Primary Outcome Measures :
  1. AUC [ Time Frame: up to 24h post-dose ]
    To evaluate AUCτ,ss of gemigliptin and AUClast of glimepiride

  2. Cmax [ Time Frame: up to 24h post-dose ]
    To evaluate Cmax,ss of gemigliptin and Cmax of glimepiride


Secondary Outcome Measures :
  1. Tmax [ Time Frame: up to 24h post-dose ]
    To evaluate Tmax,ss of gemigliptin/LC15-0636 and Tmax of glimepiride/M1

  2. t1/2β [ Time Frame: up to 24h post-dose ]
    To evaluate t1/2β of gemigliptin/LC15-0636/glimepiride/M1

  3. AUC [ Time Frame: up to 24h post-dose ]
    To evaluate AUCτ,ss of LC15-0636 and AUClast of M1

  4. Cmax [ Time Frame: up to 24h post-dose ]
    To evaluate Cmax,ss of LC15-0636 and Cmax of M1



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01768455     History of Changes
Other Study ID Numbers: LG-DPCL013
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Glimepiride
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors