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Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01426399
First Posted: August 31, 2011
Last Update Posted: December 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LG Life Sciences
  Purpose
The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration concomitantly and each alone.

Condition Intervention Phase
Healthy Drug: LC15-0444 Drug: Metformin Drug: LC15-0444+Metformin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • AUCτ,ss [ Time Frame: up to 171h30m ]
    To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444

  • Cmax,ss [ Time Frame: up to 171h 30m ]
    To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444


Secondary Outcome Measures:
  • Vital signs [ Time Frame: up to 171h30m ]
    to measure Safety and tolerability of the investigational products

  • AUECτ,ss [ Time Frame: up to 171h30m ]
    Compare the pharmacodynamic interaction between LC15-0444 and metformin in healthy male subjects This parameter is been used to measure DPP4 activity

  • AUEC [ Time Frame: up to 171h30m ]
    Compare the pharmacodynamic interaction between LC15-0444 and metformin in healthy male subjects This parameter is been used to measure Active/total GLP-1, glucose, insulin, c-peptide, glucagon.


Enrollment: 30
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LC15-0444
LC15-0444 50mg qd
Drug: LC15-0444
LC15-0444 50mg qd (8 days once daily)
Experimental: Metformin
Metformin 1000mg bid
Drug: Metformin
Metformin 1000 mg bid (8 days twice daily)
Experimental: LC15-0444+Metformin
LC15-0444 50mg qd +Metformin 1000mg bid
Drug: LC15-0444+Metformin
LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)

  Eligibility

Information from the National Library of Medicine

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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)
  • Body weight between 55kg - 90kg, 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 2months, or component blood donation in 1months or transfusion in 1months currently.
  • Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
  Contacts and Locations
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): NCT01426399


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
Investigators
Principal Investigator: Kyung-sang Yu, M.D,Ph.D Seoul national univ. hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01426399     History of Changes
Other Study ID Numbers: LG-DPCL009
First Submitted: August 22, 2011
First Posted: August 31, 2011
Last Update Posted: December 30, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs