A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP1904-3; Drug: HCP1904-1

• Registration Number: NCT05407220
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-07
• Study Start: 2022-06-29
• Primary Completion: 2022-07-25
• Study Completion: 2022-07-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group2	HCP1904-3	Period1: HCP1904-3
group1	HCP1904-1	Period1: HCP1904-1

Primary Outcome Measures

Name	Time	Method
Cmax of Losartan	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
t1/2 of Losartan	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
CL/F of Losartan	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
Vd/F of Losartan	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
AUC inf of EXP3174	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
Cmax of Chlorthalidone	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
AUC last of EXP3174	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
CL/F of EXP3174	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
Tmax of Chlorthalidone	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
t1/2 of Chlorthalidone	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
CL/F of Chlorthalidone	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
Vd/F of Chlorthalidone	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
Tmax of Losartan	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
t1/2 of EXP3174	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
AUC last of Chlorthalidone	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
AUC inf of Chlorthalidone	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
AUC last of Losartan	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
AUC inf of Losartan	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
Cmax of EXP3174	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
Tmax of EXP3174	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation
Vd/F of EXP3174	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours	pharmacokinetic evaluation

Trial Locations

Locations (1)

Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of