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
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Mar 2023
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
March 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2023
CompletedMarch 5, 2024
March 1, 2024
2 months
February 10, 2023
March 4, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (5)
AUCinf
0~72 hours
Tmax
0~72 hours
t1/2
0~72 hours
CL/F
0~72 hours
Vd/F
0~72 hours
Study Arms (2)
Sequence 1
EXPERIMENTAL* Period 1, Period 3: RLD2205 + RLD2206 * Period 2, Period 4: HCP2201
Sequence 2
EXPERIMENTAL* Period 1, Period 3: HCP2201 * Period 2, Period 4: RLD2205 + RLD2206
Interventions
Eligibility Criteria
You may qualify if:
- Age 19\~55 years in healthy male volunteers
- kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight ≥55kg
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Min-gul Kim, MD
Jeonbuk National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2023
First Posted
February 21, 2023
Study Start
March 30, 2023
Primary Completion
May 14, 2023
Study Completion
May 14, 2023
Last Updated
March 5, 2024
Record last verified: 2024-03