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.

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: RLD2006; Drug: RLD2001-2; Drug: HCP1904-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05191563

HM-CHOURS-101

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Sequence 1 (Reference-Test)

Experimental group

Description:

Period 1: RLD2001-2 + RLD2006, Period2: HCP1904-1

Treatment:

Drug: HCP1904-1

Drug: RLD2006

Drug: RLD2001-2

Sequence 2 (Test-Reference)

Experimental group

Description:

Period 1:HCP1904-1, Period 2: RLD2001-2 + RLD2006

Treatment:

Drug: HCP1904-1

Drug: RLD2006

Drug: RLD2001-2