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Completed

NCT Number: NCT05407220

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

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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

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 male volunteers
  • Weight ≥ 55kg and BMI 18 ~ 30 kg/m^2
  • Subjects who agree to use medically accepted dual contraceptives up to 14 days 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

HCP1904-3

Drug

take it once per period

Primary outcomes

  1. Cmax of Losartan

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  2. AUC last of Losartan

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  3. AUC inf of Losartan

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  4. Tmax of Losartan

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  5. t1/2 of Losartan

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  6. CL/F of Losartan

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  7. Vd/F of Losartan

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  8. Cmax of EXP3174

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  9. AUC last of EXP3174

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  10. AUC inf of EXP3174

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  11. Tmax of EXP3174

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  12. t1/2 of EXP3174

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  13. CL/F of EXP3174

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  14. Vd/F of EXP3174

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  15. Cmax of Chlorthalidone

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  16. AUC last of Chlorthalidone

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  17. AUC inf of Chlorthalidone

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  18. Tmax of Chlorthalidone

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  19. t1/2 of Chlorthalidone

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  20. CL/F of Chlorthalidone

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

  21. Vd/F of Chlorthalidone

    Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

    pharmacokinetic evaluation

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2022
Registry last updated
Oct 8, 2024

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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