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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

November 1, 2010
November 1, 2010
May 2010
August 2010   (final data collection date for primary outcome measure)
Pharmacokinetics (AUClast and Cmax) [ Time Frame: 24hours ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Healthy
  • Drug: Glucophage 500mg
    Single Oral Dose of
  • Drug: HL-018 500mg
    Single Oral Dose of
  • Other: No administration of Drug
  • Active Comparator: A
    Reference
    Intervention: Drug: Glucophage 500mg
  • Experimental: B
    Test
    Intervention: Drug: HL-018 500mg
  • Placebo Comparator: C
    Placebo
    Intervention: Other: No administration of Drug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
October 2010
August 2010   (final data collection date for primary outcome measure)

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.
Male
19 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01232036
2010-0195
No
Medical Affairs Department, HanAll Biopharma Co., Ltd.
Asan Medical Center
HanAll BioPharma Co., Ltd.
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
Asan Medical Center
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP