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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05737082

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HCP2201 Drug: RLD2205 Drug: RLD2206	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

AUCinf [0~72 hours]
Pharmacokinetic evaluation
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

Principal Investigator: Min-gul Kim, MD, Jeonbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT05737082

Other Study ID Numbers:

HM-PRADA-101

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 21, 2023