Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1903 in healthy subjects.
Eligibility Criteria
Inclusion
- Age 19\~45 years in healthy volunteers
- BMI is more than 18.5 kg/m\^2 , no more than 29.9 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 :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2021
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04762407
Start Date
November 20 2020
End Date
February 24 2021
Last Update
July 14 2022
Active Locations (1)
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1
Korea University Anam Hospital
Seoul, South Korea