A Study to Evaluate the Pharmacokinetics and Safety Between HCP2201 and Co-administration of Each Component in Healty Male Volunteers

A Randomized, Open Label, Single Dose, 4-period Replicate Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2201 and Co-administration of RLD2205 and RLD2206 in Healthy Male Volunteers Under Fasting Conditions

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2201 and co-administration of each component in fasting condition in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HCP2201; Drug: RLD2205; Drug: RLD2206

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of
      • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 19~55 years in healthy male volunteers
• 19 kg/m^2 ≤ BMI < 28 kg/m^2, weight ≥55kg
• 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1, Period 3: RLD2205 + RLD2206; Period 2, Period 4: HCP2201	Drug: HCP2201; Take 2 tablets once per period; Drug: RLD2205; Take 2 tablets once per period; Drug: RLD2206; Take 1 tablet once per period
Experimental: Sequence 2; Period 1, Period 3: HCP2201; Period 2, Period 4: RLD2205 + RLD2206	Drug: HCP2201; Take 2 tablets once per period; Drug: RLD2205; Take 2 tablets once per period; Drug: RLD2206; Take 1 tablet once per period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abiraterone acetate AUCt	Pharmacokinetic evaluation	0~72 hours
Abiraterone acetate Cmax	Pharmacokinetic evaluation	0~72 hours
Prednisolone AUCt	Pharmacokinetic evaluation	0~24 hours
Prednisolone Cmax	Pharmacokinetic evaluation	0~24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf	Pharmacokinetic evaluation	0~72 hours
Tmax	Pharmacokinetic evaluation	0~72 hours
t1/2	Pharmacokinetic evaluation	0~72 hours
CL/F	Pharmacokinetic evaluation	0~72 hours
Vd/F	Pharmacokinetic evaluation	0~72 hours

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Min-gul Kim, MD, Jeonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): May 14, 2023
• Study Completion (Actual): May 14, 2023

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HM-PRADA-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No