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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05191563
Enrollment
56
Registered
2022-01-13
Start date
2021-07-31
Completion date
2021-09-12
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGHCP1904-1

Take it once per period.

DRUGRLD2006

Take it once per period.

DRUGRLD2001-2

Take it once per period.

Sponsors

Hanmi Pharmaceutical Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
AUClast of ChlorthalidoneDay 1, Day 15:pre-dose(0 hour)~144hoursPharmacokinetic evaluation
Cmax of EXP3174Day 1, Day 15: pre-dose(0 hour)~48hoursPharmacokinetic evaluation
AUClast of EXP3174Day 1, Day 15: pre-dose(0 hour)~48hoursPharmacokinetic evaluation
Cmax of ChlorthalidoneDay 1, Day 15: pre-dose(0 hour)~144hoursPharmacokinetic evaluation
Cmax of LosartanDay 1, Day 15: pre-dose(0 hour)~48hoursPharmacokinetic evaluation
AUClast of LosartanDay 1, Day 15: pre-dose(0 hour)~48hoursPharmacokinetic evaluation

Secondary

MeasureTime frameDescription
AUC inf, Tmax, T1/2, Cl/F, Vd/F of EXP3174Day 1, Day 15: pre-dose(0 hour)~48hoursPharmacokinetic evaluation
AUC inf, Tmax, T1/2, Cl/F, Vd/F of ChlorthalidoneDay 1, Day 15:pre-dose(0 hour)~144hoursPharmacokinetic evaluation
AUC inf, Tmax, T1/2, Cl/F, Vd/F of LosartanDay 1, Day 15: pre-dose(0 hour)~48hoursPharmacokinetic evaluation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026