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.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP1904-1; Drug: RLD2006; Drug: RLD2001-2

• Registration Number: NCT05191563
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-05
• Study Start: 2021-07-31
• Primary Completion: 2021-09-12
• Study Completion: 2021-09-12
• Study First Submitted QC: 2022-01-02
• Last Update Submitted: 2022-01-02
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2 (Test-Reference)	RLD2001-2	Period 1:HCP1904-1, Period 2: RLD2001-2 + RLD2006
Sequence 2 (Test-Reference)	RLD2006	Period 1:HCP1904-1, Period 2: RLD2001-2 + RLD2006
Sequence 1 (Reference-Test)	HCP1904-1	Period 1: RLD2001-2 + RLD2006, Period2: HCP1904-1
Sequence 1 (Reference-Test)	RLD2001-2	Period 1: RLD2001-2 + RLD2006, Period2: HCP1904-1
Sequence 1 (Reference-Test)	RLD2006	Period 1: RLD2001-2 + RLD2006, Period2: HCP1904-1
Sequence 2 (Test-Reference)	HCP1904-1	Period 1:HCP1904-1, Period 2: RLD2001-2 + RLD2006

Primary Outcome Measures

Name	Time	Method
AUClast of EXP3174	Day 1, Day 15: pre-dose(0 hour)~48hours	Pharmacokinetic evaluation
Cmax of EXP3174	Day 1, Day 15: pre-dose(0 hour)~48hours	Pharmacokinetic evaluation
AUClast of Losartan	Day 1, Day 15: pre-dose(0 hour)~48hours	Pharmacokinetic evaluation
Cmax of Chlorthalidone	Day 1, Day 15: pre-dose(0 hour)~144hours	Pharmacokinetic evaluation
Cmax of Losartan	Day 1, Day 15: pre-dose(0 hour)~48hours	Pharmacokinetic evaluation
AUClast of Chlorthalidone	Day 1, Day 15:pre-dose(0 hour)~144hours	Pharmacokinetic evaluation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of