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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05737082
• Other study ID #: HM-PRADA-101
• Status: Completed
• Phase: Phase 1
• Start date: March 30, 2023
• Est. completion date: May 14, 2023

Study information

• Verified date: March 2024
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 14, 2023
• Est. primary completion date: May 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• HCP2201
Take 2 tablets once per period
• RLD2205
Take 2 tablets once per period
• RLD2206
Take 1 tablet once per period

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abiraterone acetate AUCt	Pharmacokinetic evaluation	0~72 hours
Primary	Abiraterone acetate Cmax	Pharmacokinetic evaluation	0~72 hours
Primary	Prednisolone AUCt	Pharmacokinetic evaluation	0~24 hours
Primary	Prednisolone Cmax	Pharmacokinetic evaluation	0~24 hours
Secondary	AUCinf	Pharmacokinetic evaluation	0~72 hours
Secondary	Tmax	Pharmacokinetic evaluation	0~72 hours
Secondary	t1/2	Pharmacokinetic evaluation	0~72 hours
Secondary	CL/F	Pharmacokinetic evaluation	0~72 hours
Secondary	Vd/F	Pharmacokinetic evaluation	0~72 hours