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Completed

NCT Number: NCT05191563

A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects.

An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yangji Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 19~45 years in healthy volunteers
  • BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2
  • Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.
  • Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

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

HCP1904-1

Drug

Take it once per period.

RLD2006

Drug

Take it once per period.

RLD2001-2

Drug

Take it once per period.

Primary outcomes

  1. Cmax of Losartan

    Time frame: Day 1, Day 15: pre-dose(0 hour)~48hours

    Pharmacokinetic evaluation

  2. AUClast of Losartan

    Time frame: Day 1, Day 15: pre-dose(0 hour)~48hours

    Pharmacokinetic evaluation

  3. Cmax of EXP3174

    Time frame: Day 1, Day 15: pre-dose(0 hour)~48hours

    Pharmacokinetic evaluation

  4. AUClast of EXP3174

    Time frame: Day 1, Day 15: pre-dose(0 hour)~48hours

    Pharmacokinetic evaluation

  5. Cmax of Chlorthalidone

    Time frame: Day 1, Day 15: pre-dose(0 hour)~144hours

    Pharmacokinetic evaluation

  6. AUClast of Chlorthalidone

    Time frame: Day 1, Day 15:pre-dose(0 hour)~144hours

    Pharmacokinetic evaluation

Secondary outcomes

  1. AUC inf, Tmax, T1/2, Cl/F, Vd/F of Losartan

    Time frame: Day 1, Day 15: pre-dose(0 hour)~48hours

    Pharmacokinetic evaluation

  2. AUC inf, Tmax, T1/2, Cl/F, Vd/F of EXP3174

    Time frame: Day 1, Day 15: pre-dose(0 hour)~48hours

    Pharmacokinetic evaluation

  3. AUC inf, Tmax, T1/2, Cl/F, Vd/F of Chlorthalidone

    Time frame: Day 1, Day 15:pre-dose(0 hour)~144hours

    Pharmacokinetic evaluation

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

An Open-Label, Randomized, Single-Dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2022
Registry last updated
Jan 13, 2022

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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