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Completed

NCT Number: NCT05481307

A Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interaction and Safety/Tolerability Between RLD2202 and RLD2203

The purpose of this study is to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability between RLD2202 and RLD2203 in healthy adult subjects

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

  • Inclusion Criteria:
  • Healthy adults in the age between 19 and 50 years old
  • Body mass index (BMI) in the range of 18 to 27 kg/m2 and weight 50kg to 90kg.
  • After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
  • Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
  • 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

RLD2202

Drug

Take it once a day per period

RLD2203

Drug

Take it once a day per period

Primary outcomes

  1. Cmax,ss of RLD2202

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

  2. AUCtau,ss of RLD2202

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

  3. Cmax,ss of RLD2203

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

  4. AUCtau,ss of RLD2203

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

  5. Inhibition of Platelet Aggregation(%)

    Time frame: 0~6 days

    Pharmacodynamic evaluation

  6. Inhibition of Thromboxane B2(%)

    Time frame: 0~6 days

    Pharmacodynamic evaluation

Secondary outcomes

  1. Tmax,ss of RLD2202 and RLD2203

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

  2. t1/2,ss of RLD2202 and RLD2203

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

  3. Cmin,ss of RLD2202 and RLD2203

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

  4. Cavg,ss of RLD2202 and RLD2203

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

  5. CLss/F of RLD2202 and RLD2203

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

  6. Vdss/F of RLD2202 and RLD2203

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

  7. PTF of RLD2202 and RLD2203

    Time frame: 0~24 hours

    Pharmacokinetic evaluation

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

An Open-label Phase 1 Study to Evaluate PK/PD Drug-drug Interactions and Safety/Tolerability Between RLD2202 and RLD2203 in Healthy Adult Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2022
Registry last updated
Sep 22, 2023

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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