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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01426399
First received: August 22, 2011
Last updated: December 27, 2011
Last verified: December 2011

August 22, 2011
December 27, 2011
August 2011
November 2011   (final data collection date for primary outcome measure)
  • AUCτ,ss [ Time Frame: up to 171h30m ] [ Designated as safety issue: No ]
    To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444
  • Cmax,ss [ Time Frame: up to 171h 30m ] [ Designated as safety issue: No ]
    To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444
Same as current
Complete list of historical versions of study NCT01426399 on ClinicalTrials.gov Archive Site
  • Vital signs [ Time Frame: up to 171h30m ] [ Designated as safety issue: Yes ]
    to measure Safety and tolerability of the investigational products
  • AUECτ,ss [ Time Frame: up to 171h30m ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: LC15-0444
    LC15-0444 50mg qd (8 days once daily)
  • Drug: Metformin
    Metformin 1000 mg bid (8 days twice daily)
  • Drug: LC15-0444+Metformin
    LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)
  • Experimental: LC15-0444
    LC15-0444 50mg qd
    Intervention: Drug: LC15-0444
  • Experimental: Metformin
    Metformin 1000mg bid
    Intervention: Drug: Metformin
  • Experimental: LC15-0444+Metformin
    LC15-0444 50mg qd +Metformin 1000mg bid
    Intervention: Drug: LC15-0444+Metformin
Shin D, Cho YM, Lee S, Lim KS, Kim JA, Ahn JY, Cho JY, Lee H, Jang IJ, Yu KS. Pharmacokinetic and pharmacodynamic interaction between gemigliptin and metformin in healthy subjects. Clin Drug Investig. 2014 Jun;34(6):383-93. doi: 10.1007/s40261-014-0184-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2011
November 2011   (final data collection date for primary outcome measure)

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)
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01426399
LG-DPCL009
Not Provided
LG Life Sciences
LG Life Sciences
Not Provided
Principal Investigator: Kyung-sang Yu, M.D,Ph.D Seoul national univ. hospital
LG Life Sciences
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP