Healthy
Conditions
Brief summary
A randomized, open-label, single-dose parallel study to evaluate the pharmacokinetics, safety and tolerability of HCP1803 in healthy male volunteers.
Interventions
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 19\ 45 years in healthy male volunteers 2. Weight ≥ 55kg and BMI 18 \ 30 kg/m\^2 3. Subjects who agree to use clinically accepted dual contraceptives up to 14 days after the last administration date of the investigational product and not to provide sperm. 4. 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 criteria
1. 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 2. Subjects who judged ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0~144hours | pharmacokinetic evaluation |
| AUC last | 0~144hours | pharmacokinetic evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 | 0~144hours | pharmacokinetic evaluation |
| AUC inf | 0~144hours | pharmacokinetic evaluation |
| Vd/F | 0~144hours | pharmacokinetic evaluation |
| CL/F | 0~144hours | pharmacokinetic evaluation |
| Tmax | 0~144hours | pharmacokinetic evaluation |
Countries
South Korea
Outcome results
None listed