A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP2202; Drug: RLD2202; Drug: RLD2203

• Registration Number: NCT05548543
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2202 and co-administration of each component in fed condition in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-21
• Study Start: 2022-10-17
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-22
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <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 judged ineligible by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	RLD2203	Period 1: HCP2202 Period 2: RLD2202 +RLD2203 Period 3: HCP2202 Period 4: RLD2202 +RLD2203
Sequence 1	HCP2202	Period 1: RLD2202 +RLD2203 Period 2: HCP2202 Period 3: RLD2202 +RLD2203 Period 4: HCP2202
Sequence 1	RLD2202	Period 1: RLD2202 +RLD2203 Period 2: HCP2202 Period 3: RLD2202 +RLD2203 Period 4: HCP2202
Sequence 1	RLD2203	Period 1: RLD2202 +RLD2203 Period 2: HCP2202 Period 3: RLD2202 +RLD2203 Period 4: HCP2202
Sequence 2	HCP2202	Period 1: HCP2202 Period 2: RLD2202 +RLD2203 Period 3: HCP2202 Period 4: RLD2202 +RLD2203
Sequence 2	RLD2202	Period 1: HCP2202 Period 2: RLD2202 +RLD2203 Period 3: HCP2202 Period 4: RLD2202 +RLD2203

Primary Outcome Measures

Name	Time	Method
AUCt	0~24 hours	Pharmacokinetic evaluation
Cmax	0~24 hours	Pharmacokinetic evaluation

Secondary Outcome Measures

Name	Time	Method
AUCinf	0~24 hours	Pharmacokinetic evaluation
CL/F	0~24 hours	Pharmacokinetic evaluation
t1/2	0~24 hours	Pharmacokinetic evaluation
Tmax	0~24 hours	Pharmacokinetic evaluation
Vd/F	0~24 hours	Pharmacokinetic evaluation

Trial Locations

Locations (1)

Jeonbuk University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of