A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions

NCT ID: NCT06357910

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2024-07-01

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition in healthy volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

• Period1 : RLD2302 + RLD2102
• Period2 : HCP2303

Group Type: EXPERIMENTAL

HCP2303

Intervention Type: DRUG

Take 1 tablet once per period

RLD2302

Intervention Type: DRUG

Take 1 tablet once per period

RLD2102

Intervention Type: DRUG

Take 1 tablet once per period

Arm 2

• Period1 : HCP2303
• Period2 : RLD2302 + RLD2102

Group Type: EXPERIMENTAL

HCP2303

Intervention Type: DRUG

Take 1 tablet once per period

RLD2302

Intervention Type: DRUG

Take 1 tablet once per period

RLD2102

Intervention Type: DRUG

Take 1 tablet once per period

Interventions

HCP2303

Take 1 tablet once per period

Intervention Type: DRUG

RLD2302

Take 1 tablet once per period

Intervention Type: DRUG

RLD2102

Take 1 tablet once per period

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 19~54 years in healthy volunteers
• 18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
• 90 mmHg ≤ sitSBP <140 mmHg, 50 mmHg ≤ sitDBP <90 mmHg
• Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug
• Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria

• 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 cannot consume the high-fat meal provided during this clinical trial
• Subjects who judged ineligible by the investigator

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min-gul Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Jeonbuk National University Hospital

Locations

Jeonbuk University Hospital

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

Other Identifiers

HM-EMMA-102

Identifier Type: -

Identifier Source: org_study_id