Clinical Trial to Compare the Pharmacokinetics and Pharmacodynamics After Oral Administration of Glucophage and HL-018

Phase 1CompletedNCT01232036

Asan Medical Center28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Glucophage 500mgDRUG

Single Oral Dose of

HL-018 500mgDRUG

Single Oral Dose of

No administration of DrugOTHER

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Pharmacokinetics (AUClast and Cmax)

Time frame: 24hours

Data from ClinicalTrials.gov

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