Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.
Eligibility Criteria
Inclusion
- Age 19\~45 years in healthy male volunteers
- Weight ≥ 55kg and BMI 18 \~ 30 kg/m\^2
- Subjects who agree to use medically accepted dual contraceptives up to 14 days after the last administration date of the clinical trial drug and not to provide sperm.
- 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 :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05407220
Start Date
June 29 2022
End Date
July 25 2022
Last Update
October 8 2024
Active Locations (1)
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1
Yangji Hospital
Seoul, South Korea