Clinical trial NCT05407220: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.
Official title: A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 16
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 medically accepted dual contraceptives up to 14 days after the last administration date of the clinical trial drug 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

Primary outcomes:
measure: Cmax of Losartan
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: AUC last of Losartan
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: AUC inf of Losartan
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: Tmax of Losartan
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: t1/2 of Losartan
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: CL/F of Losartan
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: Vd/F of Losartan
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: Cmax of EXP3174
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: AUC last of EXP3174
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: AUC inf of EXP3174
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: Tmax of EXP3174
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: t1/2 of EXP3174
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: CL/F of EXP3174
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: Vd/F of EXP3174
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: Cmax of Chlorthalidone
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: AUC last of Chlorthalidone
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: AUC inf of Chlorthalidone
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: Tmax of Chlorthalidone
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: t1/2 of Chlorthalidone
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: CL/F of Chlorthalidone
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
measure: Vd/F of Chlorthalidone
timeFrame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yangji Hospital
Study officials:
References: