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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01232036

Enrollment

Registered

2010-11-02

Start date

2010-05-31

Completion date

2010-10-31

Last updated

2010-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy volunteers

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

Interventions

DRUGGlucophage 500mg

Single Oral Dose of

DRUGHL-018 500mg

Single Oral Dose of

OTHERNo administration of Drug

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics (AUClast and Cmax)	24hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026