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

This study has been completed.
Sponsor:
Collaborator:
HanAll BioPharma Co., Ltd.
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01232036
First received: November 1, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Glucophage 500mg
Drug: HL-018 500mg
Other: No administration of Drug
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Pharmacokinetics (AUClast and Cmax) [ Time Frame: 24hours ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Reference
 Drug: Glucophage 500mg
Single Oral Dose of
Experimental: B
Test
 Drug: HL-018 500mg
Single Oral Dose of
Placebo Comparator: C
Placebo
 Other: No administration of Drug

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232036

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
HanAll BioPharma Co., Ltd.
Investigators
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
  More Information

Additional Information:
Clinical Research Center, Asan Medical Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Department, HanAll Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01232036     History of Changes
Other Study ID Numbers: 2010-0195
Study First Received: November 1, 2010
Last Updated: November 1, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
healthy volunteers

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013