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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP2201; Drug: RLD2205; Drug: RLD2206

• Registration Number: NCT05737082
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-21
• Study Start: 2023-03-30
• Primary Completion: 2023-05-14
• Study Completion: 2023-05-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	HCP2201	* Period 1, Period 3: RLD2205 + RLD2206 * Period 2, Period 4: HCP2201
Sequence 1	RLD2206	* Period 1, Period 3: RLD2205 + RLD2206 * Period 2, Period 4: HCP2201
Sequence 2	HCP2201	* Period 1, Period 3: HCP2201 * Period 2, Period 4: RLD2205 + RLD2206
Sequence 2	RLD2205	* Period 1, Period 3: HCP2201 * Period 2, Period 4: RLD2205 + RLD2206
Sequence 2	RLD2206	* Period 1, Period 3: HCP2201 * Period 2, Period 4: RLD2205 + RLD2206
Sequence 1	RLD2205	* Period 1, Period 3: RLD2205 + RLD2206 * Period 2, Period 4: HCP2201

Primary Outcome Measures

Name	Time	Method
Abiraterone acetate AUCt	0~72 hours	Pharmacokinetic evaluation
Abiraterone acetate Cmax	0~72 hours	Pharmacokinetic evaluation
Prednisolone AUCt	0~24 hours	Pharmacokinetic evaluation
Prednisolone Cmax	0~24 hours	Pharmacokinetic evaluation

Secondary Outcome Measures

Name	Time	Method
Tmax	0~72 hours	Pharmacokinetic evaluation
t1/2	0~72 hours	Pharmacokinetic evaluation
CL/F	0~72 hours	Pharmacokinetic evaluation
Vd/F	0~72 hours	Pharmacokinetic evaluation
AUCinf	0~72 hours	Pharmacokinetic evaluation

Trial Locations

Locations (1)

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