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Completed

NCT Number: NCT05862090

A Study to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 in Healthy Volunteers

The purpose of this study is to evaluate the drug-drug interaction and safety of RLD2301 and RLD2007 after oral administration in healthy volunteers.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jeonbuk 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 19~54 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
  • 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

RLD2301

Drug

Take it once a day per period.

RLD2007

Drug

Take it once a day per period.

Primary outcomes

  1. AUCtau

    Time frame: 0~24 hours after final dose administration

    Pharmacokinetic evaluation

  2. Css,max

    Time frame: 0~24 hours after final dose administration

    Pharmacokinetic evaluation

Secondary outcomes

  1. Css,min

    Time frame: 0~24 hours after final dose administration

    Pharmacokinetic evaluation

  2. Css,av

    Time frame: 0~24 hours after final dose administration

    Pharmacokinetic evaluation

  3. Tss,max

    Time frame: 0~24 hours after final dose administration

    Pharmacokinetic evaluation

  4. t1/2

    Time frame: 0~24 hours after final dose administration

    Pharmacokinetic evaluation

  5. CLss/F

    Time frame: 0~24 hours after final dose administration

    Pharmacokinetic evaluation

  6. Vdss/F

    Time frame: 0~24 hours after final dose administration

    Pharmacokinetic evaluation

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

    Time frame: 0~24 hours after final dose administration

    Pharmacokinetic evaluation

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

    Time frame: 0~24 hours after final dose administration

    Pharmacokinetic evaluation

Other outcomes

  1. Change of Blood Pressure(SBP/DBP) from baseline

    Time frame: Predose at Day1 and 0~24 hours after final dose administration of each period

    Pharmacodynamic evaluation

  2. Change of pulse rate from baseline

    Time frame: Predose at Day1 and 0~24 hours after final dose administration of each period

    Pharmacodynamic evaluation

  3. Change of blood glucose from baseline

    Time frame: Predose at Day1 and 0~24 hours after final dose administration of each period

    Pharmacodynamic evaluation

  4. AUECtau of Blood Pressure(SBP/DBP)

    Time frame: Predose at Day1 and 0~24 hours after final dose administration of each period

    Pharmacodynamic evaluation

  5. AUECtau of pulse rate

    Time frame: Predose at Day1 and 0~24 hours after final dose administration of each period

    Pharmacodynamic evaluation

  6. AUECtau of blood glucose

    Time frame: Predose at Day1 and 0~24 hours after final dose administration of each period

    Pharmacodynamic evaluation

  7. Emax of Blood Pressure(SBP/DBP)

    Time frame: Predose at Day1 and 0~24 hours after final dose administration of each period

    Pharmacodynamic evaluation

  8. Emax of pulse rate

    Time frame: Predose at Day1 and 0~24 hours after final dose administration of each period

    Pharmacodynamic evaluation

  9. Emax of blood glucose

    Time frame: Predose at Day1 and 0~24 hours after final dose administration of each period

    Pharmacodynamic evaluation

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

An Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 After Oral Administration in Healthy Volunteers

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 17, 2023
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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