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
1 other identifier
interventional
56
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jul 2021
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2021
CompletedStudy Start
First participant enrolled
July 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2022
CompletedJanuary 13, 2022
July 1, 2021
1 month
July 5, 2021
January 2, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (3)
AUC inf, Tmax, T1/2, Cl/F, Vd/F of Losartan
Day 1, Day 15: pre-dose(0 hour)~48hours
AUC inf, Tmax, T1/2, Cl/F, Vd/F of EXP3174
Day 1, Day 15: pre-dose(0 hour)~48hours
AUC inf, Tmax, T1/2, Cl/F, Vd/F of Chlorthalidone
Day 1, Day 15:pre-dose(0 hour)~144hours
Study Arms (2)
Sequence 1 (Reference-Test)
EXPERIMENTALPeriod 1: RLD2001-2 + RLD2006, Period2: HCP1904-1
Sequence 2 (Test-Reference)
EXPERIMENTALPeriod 1:HCP1904-1, Period 2: RLD2001-2 + RLD2006
Interventions
Eligibility Criteria
You may qualify if:
- Age 19\~45 years in healthy volunteers
- BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
- 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.
- 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
You may not qualify if:
- 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
- Subjects who judged ineligible by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yangji Hospital
Seoul, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2021
First Posted
January 13, 2022
Study Start
July 31, 2021
Primary Completion
September 12, 2021
Study Completion
September 12, 2021
Last Updated
January 13, 2022
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share