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Completed

NCT Number: NCT05155995

A Study to Evaluate the Pharmacokinetics and Safety Between HCP2001 and Co-administration of Each Component in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2001 and co-administration of each component in fasting and fed conditions respectively 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

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 19~54 years in healthy volunteers 19 kg/m^2 ≤ BMI < 28 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

HCP2001

Drug

Take it once per period.

RLD2007

Drug

Take it once per period.

RLD2008

Drug

Take it once per period.

RLD2102

Drug

Take it once per period.

Primary outcomes

  1. AUCt

    Time frame: 0~48hr

    Pharmacokinetic evaluation

  2. Cmax

    Time frame: 0~48hr

    Pharmacokinetic evaluation

Secondary outcomes

  1. AUCinf

    Time frame: 0~48hr

    Pharmacokinetic evaluation

  2. Tmax

    Time frame: 0~48hr

    Pharmacokinetic evaluation

  3. t1/2

    Time frame: 0~48hr

    Pharmacokinetic evaluation

  4. CL/F

    Time frame: 0~48hr

    Pharmacokinetic evaluation

  5. Vd/F

    Time frame: 0~48hr

    Pharmacokinetic evaluation

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between After Administration of a Fixed-dose Combination Drug of HCP2001 and Co-administration of Each Component in Healthy Volunteers

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 14, 2021
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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