A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects.

An Open-Label, Randomized, Single-Dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Subjects

An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HCP1904-1; Drug: RLD2006; Drug: RLD2001-2

• Study Type: Interventional
• Enrollment (Actual): 56
• 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: All

Description

Inclusion Criteria:

1. Age 19~45 years in healthy volunteers
2. BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2
3. Subjects who agree to use medically accepted dual contraceptives up to two months 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: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1 (Reference-Test); Period 1: RLD2001-2 + RLD2006, Period2: HCP1904-1	Drug: HCP1904-1; Take it once per period.; Drug: RLD2006; Take it once per period.; Drug: RLD2001-2; Take it once per period.
Experimental: Sequence 2 (Test-Reference); Period 1:HCP1904-1, Period 2: RLD2001-2 + RLD2006	Drug: HCP1904-1; Take it once per period.; Drug: RLD2006; Take it once per period.; Drug: RLD2001-2; 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, Day 15: pre-dose(0 hour)~48hours
AUClast of Losartan	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~48hours
Cmax of EXP3174	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~48hours
AUClast of EXP3174	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~48hours
Cmax of Chlorthalidone	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~144hours
AUClast of Chlorthalidone	Pharmacokinetic evaluation	Day 1, Day 15:pre-dose(0 hour)~144hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC inf, Tmax, T1/2, Cl/F, Vd/F of Losartan	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~48hours
AUC inf, Tmax, T1/2, Cl/F, Vd/F of EXP3174	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~48hours
AUC inf, Tmax, T1/2, Cl/F, Vd/F of Chlorthalidone	Pharmacokinetic evaluation	Day 1, Day 15:pre-dose(0 hour)~144hours

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2021
• Primary Completion (Actual): September 12, 2021
• Study Completion (Actual): September 12, 2021

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: January 2, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 2, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HM-CHOURS-101

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