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

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

Overview[ - collapse ][ - ]

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	Healthy
Intervention	Drug: LC15-0444 Drug: Metformin Drug: LC15-0444+Metformin
Phase	Phase 1
Sponsor	LG Life Sciences
Responsible Party	LG Life Sciences
ClinicalTrials.gov Identifier	NCT01426399
First Received	August 22, 2011
Last Updated	December 27, 2011
Last verified	December 2011

Tracking Information[ + expand ][ + ]

First Received Date	August 22, 2011
Last Updated Date	December 27, 2011
Start Date	August 2011
Estimated Primary Completion Date	December 2011
Current Primary Outcome Measures	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
Current Secondary Outcome Measures	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.

Descriptive Information[ + expand ][ + ]

Brief Title	Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects
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
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Healthy
Intervention	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)
Study Arm (s)	Experimental: LC15-0444 LC15-0444 50mg qd Experimental: Metformin Metformin 1000mg bid Experimental: LC15-0444+Metformin LC15-0444 50mg qd +Metformin 1000mg bid

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	30
Estimated Completion Date	December 2011
Estimated Primary Completion Date	November 2011
Eligibility 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)
Gender	Male
Ages	20 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01426399
Other Study ID Numbers	LG-DPCL009
Has Data Monitoring Committee	Not Provided
Information Provided By	LG Life Sciences
Study Sponsor	LG Life Sciences
Collaborators	Not Provided
Investigators	Principal Investigator: Kyung-sang Yu, M.D,Ph.D Seoul national univ. hospital
Verification Date	December 2011

Locations[ + expand ][ + ]