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

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ClinicalTrials.gov Identifier: NCT01232036
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : November 2, 2010
Information provided by:

Study Description
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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : May 2010
Primary Completion Date : August 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
Drug: Glucophage 500mg
Single Oral Dose of
Experimental: B
Drug: HL-018 500mg
Single Oral Dose of
Placebo Comparator: C
Other: No administration of Drug

Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics (AUClast and Cmax) [ Time Frame: 24hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232036

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

Additional Information:
Responsible Party: Medical Affairs Department, HanAll Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01232036     History of Changes
Other Study ID Numbers: 2010-0195
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: October 2010

Keywords provided by Asan Medical Center:
healthy volunteers

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs