Status:
COMPLETED
Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy Volunteers
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
Study Design * Open, escalating single-dose design. * 7 ascending dose cohorts * In each cohorts, subjects will receive a single dose of HM61713. * Main objective of this study is to evaluate the pha...
Detailed Description
Primary objectives • To assess the PK characteristics of HM61713 and metabolites in healthy male volunteers Secondary objectives * To assess the safety and tolerability of HM61713 tablet in healthy...
Eligibility Criteria
Inclusion
- Healthy male volunteers, age between 20 and 45
- Informed of the investigational nature of this study and voluntarily agree to participate in this study
- BMI of \>18.5kg/m2 and \<28kg/m2 subject
Exclusion
- Use of any prescription medication within 2 weeks prior to Day 1
- Use of any medication within 1 weeks prior to Day 1
- Has a severe medical history of hypersensitivity to drug
- Participation in another clinical study within 8 weeks days prior to start of study drug administration
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01894399
Start Date
September 1 2013
End Date
November 1 2013
Last Update
December 15 2016
Active Locations (1)
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1
Research Site
Seoul, South Korea