A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.
Overview
- Phase
- Phase 1
- Intervention
- HCP1904-1
- Conditions
- Healthy
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Cmax of Losartan
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 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 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 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: HCP1904-1
Intervention: HCP1904-1
group2
Period1: HCP1904-3
Intervention: HCP1904-3
Outcomes
Primary Outcomes
Cmax of Losartan
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
t1/2 of Losartan
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
CL/F of Losartan
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Vd/F of Losartan
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC inf of EXP3174
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Cmax of Chlorthalidone
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC last of EXP3174
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
CL/F of EXP3174
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Tmax of Chlorthalidone
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
t1/2 of Chlorthalidone
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
CL/F of Chlorthalidone
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Vd/F of Chlorthalidone
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Tmax of Losartan
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
t1/2 of EXP3174
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC last of Chlorthalidone
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC inf of Chlorthalidone
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC last of Losartan
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC inf of Losartan
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Cmax of EXP3174
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Tmax of EXP3174
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Vd/F of EXP3174
Time Frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation