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Completed

NCT Number: NCT04762407

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1903 in healthy subjects.

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Anam 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 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

HGP1910

Drug

Take it once per period.

HGP1909

Drug

Take it once per period.

HCP1903

Drug

Take it once per period.

Primary outcomes

  1. Cmax of Rosuvastatin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  2. AUClast of Rosuvastatin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  3. Cmax of Free Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  4. AUClast of Free Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

Secondary outcomes

  1. Cmax of Total Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  2. AUClast of Total Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  3. AUCinf of Rosuvastatin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  4. Tmax of Rosuvastatin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  5. t1/2 of Rosuvastatin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  6. CL/F of Rosuvastatin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  7. Vd/F of Rosuvastatin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  8. AUCinf of Free Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  9. Tmax of Free Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  10. t1/2 of Free Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  11. CL/F of Free Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  12. Vd/F of Free Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  13. AUCinf of Total Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  14. Tmax of Total Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  15. t1/2 of Total Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  16. CL/F of Total Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    pharmacokinetic evaluation

  17. Vd/F of Total Ezetimibe

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    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 HCP1903 in Healthy Subjects

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Jul 14, 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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