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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Glucophage 500mg; Drug: HL-018 500mg; Other: No administration of Drug

• Registration Number: NCT01232036
• Lead Sponsor: Asan Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2010-08
• Status Verified: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-01
• Last Update Submitted: 2010-11-01
• Study First Posted: 2010-11-02
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Glucophage 500mg	Reference
B	HL-018 500mg	Test
C	No administration of Drug	Placebo

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (AUClast and Cmax)	24hours

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of