NCT05723549
Completed
Phase 1
A Randomized, Open-label, Single-Dose, Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1803 in Healthy Male Volunteers.
Hanmi Pharmaceutical Company Limited1 site in 1 country20 target enrollmentFebruary 2, 2023
Overview
- Phase
- Phase 1
- Intervention
- HCP1803-3
- Conditions
- Healthy
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
A randomized, open-label, single-dose parallel study to evaluate the pharmacokinetics, safety and tolerability of HCP1803 in healthy male volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 19\~45 years in healthy male volunteers
- •Weight ≥ 55kg and BMI 18 \~ 30 kg/m\^2
- •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.
- •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
- •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
Arms & Interventions
group1
Period1 : HCP1803-3
Intervention: HCP1803-3
group2
Period1 : RLD2002, HCP1904-1
Intervention: RLD2002
group2
Period1 : RLD2002, HCP1904-1
Intervention: HCP1904-1
Outcomes
Primary Outcomes
Cmax
Time Frame: 0~144hours
pharmacokinetic evaluation
AUC last
Time Frame: 0~144hours
pharmacokinetic evaluation
Secondary Outcomes
- t1/2(0~144hours)
- CL/F(0~144hours)
- AUC inf(0~144hours)
- Tmax(0~144hours)
- Vd/F(0~144hours)
Study Sites (1)
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