NCT01232036

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2010

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
Last Updated

November 2, 2010

Status Verified

October 1, 2010

Enrollment Period

3 months

First QC Date

November 1, 2010

Last Update Submit

November 1, 2010

Conditions

Healthy

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (AUClast and Cmax)

    24hours

Study Arms (3)

A

ACTIVE COMPARATOR

Reference

Drug: Glucophage 500mg

B

EXPERIMENTAL

Test

Drug: HL-018 500mg

C

PLACEBO COMPARATOR

Placebo

Other: No administration of Drug

Interventions

Glucophage 500mgDRUG

Single Oral Dose of

A
HL-018 500mgDRUG

Single Oral Dose of

B
No administration of DrugOTHER
C

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Links

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Kyun-Seop Bae, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

November 2, 2010

Record last verified: 2010-10

Locations

KR(1)