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Completed

NCT Number: NCT06518122

A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers

The purpose of this study is to evaluate the drug-drug interaction and safety between HCP1306, RLD2302 and RLD2102 in healthy volunteers.

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Key information

Conditions

Healthy

Age range

19 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

About this study

[PART A] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302

[PART B] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302, RLD2102

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 19~54 years in healthy volunteers
  • 18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
  • 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 or eggs 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

HCP1306

Drug

Take it once a day per period.

RLD2302

Drug

Take it once a day per period.

RLD2102

Drug

Take it once a day per period

Primary outcomes

  1. AUCtau

    Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

    Pharmacokinetic evaluation

  2. Css,max

    Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

    Pharmacokinetic evaluation

Secondary outcomes

  1. Css,min

    Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

    Pharmacokinetic evaluation

  2. Css,av

    Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

    Pharmacokinetic evaluation

  3. Tss,max

    Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

    Pharmacokinetic evaluation

  4. t1/2

    Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

    Pharmacokinetic evaluation

  5. CLss/F

    Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

    Pharmacokinetic evaluation

  6. Vdss/F

    Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

    Pharmacokinetic evaluation

  7. Fluctuation[(Css,max-Css,min)/Css,av]

    Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

    Pharmacokinetic evaluation

  8. Swing[(Css,max-Css,min)/Css,min]

    Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

    Pharmacokinetic evaluation

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Feb 20, 2025

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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