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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05737082
Enrollment
44
Registered
2023-02-21
Start date
2023-03-30
Completion date
2023-05-14
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGHCP2201

Take 2 tablets once per period

DRUGRLD2205

Take 2 tablets once per period

DRUGRLD2206

Take 1 tablet once per period

Sponsors

Hanmi Pharmaceutical Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Abiraterone acetate AUCt0~72 hoursPharmacokinetic evaluation
Abiraterone acetate Cmax0~72 hoursPharmacokinetic evaluation
Prednisolone AUCt0~24 hoursPharmacokinetic evaluation
Prednisolone Cmax0~24 hoursPharmacokinetic evaluation

Secondary

MeasureTime frameDescription
AUCinf0~72 hoursPharmacokinetic evaluation
Vd/F0~72 hoursPharmacokinetic evaluation
Tmax0~72 hoursPharmacokinetic evaluation
t1/20~72 hoursPharmacokinetic evaluation
CL/F0~72 hoursPharmacokinetic evaluation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026