Status:
COMPLETED
Pharmacokinetics of HCP1305 and Co-administration of HCP0605, HGP0816 in Healthy Male Volunteers
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
To investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers
Detailed Description
The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers
Eligibility Criteria
Inclusion
- Healthy male volunteer, age 19\~45 years
- Weight is not less than 55kg, no more than 90kg and Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- Subjects who judged ineligible by the investigator.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04039724
Start Date
February 1 2015
End Date
May 1 2015
Last Update
July 31 2019
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea