Clinical Trial to Compare the Pharmacokinetics and Pharmacodynamics After Oral Administration of Glucophage and HL-018
NCT ID: NCT01232036
Last Updated: 2010-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2010-05-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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A
Reference
Glucophage 500mg
Single Oral Dose of
B
Test
HL-018 500mg
Single Oral Dose of
C
Placebo
No administration of Drug
Interventions
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Glucophage 500mg
Single Oral Dose of
HL-018 500mg
Single Oral Dose of
No administration of Drug
Eligibility Criteria
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Inclusion Criteria
* 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 of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
* History of known hypersensitivity to drugs including metformin.
19 Years
50 Years
MALE
Yes
Sponsors
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HanAll BioPharma Co., Ltd.
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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HanAll Biopharma Co., Ltd.
Principal Investigators
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Kyun-Seop Bae, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Related Links
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Clinical Research Center, Asan Medical Center
Other Identifiers
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2010-0195
Identifier Type: -
Identifier Source: org_study_id