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

Sponsor
Hanmi Pharmaceutical Company Limited (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05407220
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
1.2
Anticipated Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.
Anticipated Study Start Date :
Jun 8, 2022
Anticipated Primary Completion Date :
Jul 16, 2022
Anticipated Study Completion Date :
Jul 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: group1

Period1: HCP1904-1

Drug: HCP1904-1
take it once per period
Experimental: group2

Period1: HCP1904-3

Drug: HCP1904-3
take it once per period

Outcome Measures

Primary Outcome Measures

  1. Cmax of Losartan [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  2. AUC last of Losartan [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  3. AUC inf of Losartan [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  4. Tmax of Losartan [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  5. t1/2 of Losartan [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  6. CL/F of Losartan [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  7. Vd/F of Losartan [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  8. Cmax of EXP3174 [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  9. AUC last of EXP3174 [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  10. AUC inf of EXP3174 [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  11. Tmax of EXP3174 [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  12. t1/2 of EXP3174 [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  13. CL/F of EXP3174 [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  14. Vd/F of EXP3174 [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  15. Cmax of Chlorthalidone [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  16. AUC last of Chlorthalidone [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  17. AUC inf of Chlorthalidone [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  18. Tmax of Chlorthalidone [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  19. t1/2 of Chlorthalidone [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  20. CL/F of Chlorthalidone [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

  21. Vd/F of Chlorthalidone [Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours]

    pharmacokinetic evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Age 19~45 years in healthy male volunteers

  2. Weight ≥ 55kg and BMI 18 ~ 30 kg/m^2

  3. 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.

  4. 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:

  1. 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

  2. Subjects who judged ineligible by the investigator

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yangji Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT05407220
Other Study ID Numbers:
  • HM-CHORUS-102
First Posted:
Jun 7, 2022
Last Update Posted:
Jun 7, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 7, 2022