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Completed

NCT Number: NCT01426399

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.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LC15-0444

Drug

LC15-0444 50mg qd (8 days once daily)

metformin

Drug

Metformin 1000 mg bid (8 days twice daily)

LC15-0444+Metformin

Drug

LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)

Primary outcomes

  1. AUCτ,ss

    Time frame: up to 171h30m

    To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444

  2. Cmax,ss

    Time frame: up to 171h 30m

    To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444

Secondary outcomes

  1. Vital signs

    Time frame: up to 171h30m

    to measure Safety and tolerability of the investigational products

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 31, 2011
Registry last updated
Dec 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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