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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LC15-0444; Drug: Metformin; Drug: LC15-0444+Metformin

• Registration Number: NCT01426399
• Lead Sponsor: LG Life Sciences

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-31
• Primary Completion: 2011-11
• Status Verified: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-27
• Last Update Posted: 2011-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LC15-0444	LC15-0444	LC15-0444 50mg qd
Metformin	Metformin	Metformin 1000mg bid
LC15-0444+Metformin	LC15-0444+Metformin	LC15-0444 50mg qd +Metformin 1000mg bid

Primary Outcome Measures

Name	Time	Method
AUCτ,ss	up to 171h30m	To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444
Cmax,ss	up to 171h 30m	To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444

Secondary Outcome Measures

Name	Time	Method
Vital signs	up to 171h30m	to measure Safety and tolerability of the investigational products
AUECτ,ss	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	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of