A Clinical Trial to Compare the Pharmacokinetic and Pharmacodynamic Characteristics and Safety After Oral Administration of Glucophage With Those After Oral Administration of HL-018 in Healthy Male Volunteers

Asan Medical Center1 site in 1 country28 target enrollmentMay 2010

ConditionsHealthy

InterventionsGlucophage 500mg HL-018 500mg No administration of Drug

DrugsGlucophage 500mg HL-018 500mg

Overview

Phase: Phase 1
Intervention: Glucophage 500mg
Conditions: Healthy
Sponsor: Asan Medical Center
Enrollment: 28
Locations: 1
Primary Endpoint: Pharmacokinetics (AUClast and Cmax)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to to compare the pharmacokinetic and pharmacodynamic characteristics and safety after oral administration of Glucophage with those after oral administration of HL-018 in healthy male volunteers

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

October 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

•Adult males aged 19 to 50 years at screening.
•No significant congenital/chronic disease. No symptoms in physical examination.
•Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
•Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria

•History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
•History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
•History of known hypersensitivity to drugs including metformin.