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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP2303; Drug: RLD2302; Drug: RLD2102

• Registration Number: NCT06346184
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-03
• Study Start: 2024-05-02
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-14
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 judged ineligible by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	HCP2303	* Period1 : RLD2302 + RLD2102 * Period2 : HCP2303
Arm 1	RLD2302	* Period1 : RLD2302 + RLD2102 * Period2 : HCP2303
Arm 1	RLD2102	* Period1 : RLD2302 + RLD2102 * Period2 : HCP2303
Arm 2	HCP2303	* Period1 : HCP2303 * Period2 : RLD2302 + RLD2102
Arm 2	RLD2302	* Period1 : HCP2303 * Period2 : RLD2302 + RLD2102
Arm 2	RLD2102	* Period1 : HCP2303 * Period2 : RLD2302 + RLD2102

Primary Outcome Measures

Name	Time	Method
AUCt	0~48 hours	Pharmacokinetic evaluation
Cmax	0~48 hours	Pharmacokinetic evaluation

Secondary Outcome Measures

Name	Time	Method
Vd/F	0~48 hours	Pharmacokinetic evaluation
AUCinf	0~48 hours	Pharmacokinetic evaluation
Tmax	0~48 hours	Pharmacokinetic evaluation
t1/2	0~48 hours	Pharmacokinetic evaluation
CL/F	0~48 hours	Pharmacokinetic evaluation

Trial Locations

Locations (1)

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