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Completed

NCT Number: NCT05737082

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

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.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCP2201

Drug

Take 2 tablets once per period

RLD2205

Drug

Take 2 tablets once per period

RLD2206

Drug

Take 1 tablet once per period

Primary outcomes

  1. Abiraterone acetate AUCt

    Time frame: 0~72 hours

    Pharmacokinetic evaluation

  2. Abiraterone acetate Cmax

    Time frame: 0~72 hours

    Pharmacokinetic evaluation

  3. Prednisolone AUCt

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

  4. Prednisolone Cmax

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

Secondary outcomes

  1. AUCinf

    Time frame: 0~72 hours

    Pharmacokinetic evaluation

  2. Tmax

    Time frame: 0~72 hours

    Pharmacokinetic evaluation

  3. t1/2

    Time frame: 0~72 hours

    Pharmacokinetic evaluation

  4. CL/F

    Time frame: 0~72 hours

    Pharmacokinetic evaluation

  5. Vd/F

    Time frame: 0~72 hours

    Pharmacokinetic evaluation

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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