Status:
COMPLETED
PK and Safety Study of HCP1102, HGP0813 and HGP1408
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
This study is a randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of HCP1102 in comparison to HGP0813 and HGP1408 admini...
Eligibility Criteria
Inclusion
- Age 19\~45 years in healthy male volunteers
- BMI is more than 19kg/m\^2 , no more than 28.0 kg/m\^2
- 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 digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
Key Trial Info
Start Date :
July 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03371849
Start Date
July 19 2017
End Date
August 3 2017
Last Update
December 13 2017
Active Locations (1)
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1
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea