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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: HCP1904-1; Drug: HCP1904-3

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group1; Period1: HCP1904-1	Drug: HCP1904-1; take it once per period
Experimental: group2; Period1: HCP1904-3	Drug: HCP1904-3; take it once per period

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Anticipated): June 8, 2022
• Primary Completion (Anticipated): July 16, 2022
• Study Completion (Anticipated): July 16, 2022

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HM-CHORUS-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No