Status:
COMPLETED
Clinical Trial to Compare the Pharmacokinetics and Pharmacodynamics After Oral Administration of Glucophage and HL-018
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
HanAll BioPharma Co., Ltd.
Conditions:
Healthy
Eligibility:
MALE
19-50 years
Phase:
PHASE1
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 health...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01232036
Start Date
May 1 2010
End Date
October 1 2010
Last Update
November 2 2010
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea