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.

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05191563
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.4
• Patients Per Site Per Month: 39.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HCP1904-1; Drug: RLD2006; Drug: RLD2001-2	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Randomized, Single-Dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Subjects
• Actual Study Start Date: Jul 31, 2021
• Actual Primary Completion Date: Sep 12, 2021
• Actual Study Completion Date: Sep 12, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Cmax of Losartan [Day 1, Day 15: pre-dose(0 hour)~48hours]

   Pharmacokinetic evaluation

2. AUClast of Losartan [Day 1, Day 15: pre-dose(0 hour)~48hours]

   Pharmacokinetic evaluation

3. Cmax of EXP3174 [Day 1, Day 15: pre-dose(0 hour)~48hours]

   Pharmacokinetic evaluation

4. AUClast of EXP3174 [Day 1, Day 15: pre-dose(0 hour)~48hours]

   Pharmacokinetic evaluation

5. Cmax of Chlorthalidone [Day 1, Day 15: pre-dose(0 hour)~144hours]

   Pharmacokinetic evaluation

6. AUClast of Chlorthalidone [Day 1, Day 15:pre-dose(0 hour)~144hours]

   Pharmacokinetic evaluation

Secondary Outcome Measures

1. AUC inf, Tmax, T1/2, Cl/F, Vd/F of Losartan [Day 1, Day 15: pre-dose(0 hour)~48hours]

   Pharmacokinetic evaluation

2. AUC inf, Tmax, T1/2, Cl/F, Vd/F of EXP3174 [Day 1, Day 15: pre-dose(0 hour)~48hours]

   Pharmacokinetic evaluation

3. AUC inf, Tmax, T1/2, Cl/F, Vd/F of Chlorthalidone [Day 1, Day 15:pre-dose(0 hour)~144hours]

   Pharmacokinetic evaluation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yangji Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT05191563
• Other Study ID Numbers: HM-CHOURS-101
• First Posted: Jan 13, 2022
• Last Update Posted: Jan 13, 2022
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 13, 2022