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CompletedNCT04762407Updated Jul 14, 2022

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

A Phase 1 interventional study of HGP1910 and HGP1909 in Healthy, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age 19\~45 years in healthy volunteers
  2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
  3. 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Sequence 1

    Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903

    Drug: HGP1910 · Drug: HGP1909 · Drug: HCP1903

  • Experimental
    Sequence 2

    Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909

    Drug: HGP1910 · Drug: HGP1909 · Drug: HCP1903

Interventions

  • DrugHGP1910

    Take it once per period.

  • DrugHGP1909

    Take it once per period.

  • DrugHCP1903

    Take it once per period.

06

What researchers measure

Primary outcomes

  1. Cmax of Rosuvastatin

    pharmacokinetic evaluation

    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

  2. AUClast of Rosuvastatin

    pharmacokinetic evaluation

    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

  3. Cmax of Free Ezetimibe

    pharmacokinetic evaluation

    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

  4. AUClast of Free Ezetimibe

    pharmacokinetic evaluation

    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

Secondary outcomes

  1. Cmax of Total Ezetimibe

    pharmacokinetic evaluation

    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

  2. AUClast of Total Ezetimibe

    pharmacokinetic evaluation

    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

  3. AUCinf of Rosuvastatin

    pharmacokinetic evaluation

    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

  4. Tmax of Rosuvastatin

    pharmacokinetic evaluation

    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

  5. t1/2 of Rosuvastatin

    pharmacokinetic evaluation

    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

  6. CL/F of Rosuvastatin

    pharmacokinetic evaluation

    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

  7. Vd/F of Rosuvastatin

    pharmacokinetic evaluation

    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

  8. AUCinf of Free Ezetimibe

    pharmacokinetic evaluation

    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

  9. Tmax of Free Ezetimibe

    pharmacokinetic evaluation

    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

  10. t1/2 of Free Ezetimibe

    pharmacokinetic evaluation

    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

  11. CL/F of Free Ezetimibe

    pharmacokinetic evaluation

    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

  12. Vd/F of Free Ezetimibe

    pharmacokinetic evaluation

    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

  13. AUCinf of Total Ezetimibe

    pharmacokinetic evaluation

    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

  14. Tmax of Total Ezetimibe

    pharmacokinetic evaluation

    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

  15. t1/2 of Total Ezetimibe

    pharmacokinetic evaluation

    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

  16. CL/F of Total Ezetimibe

    pharmacokinetic evaluation

    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

  17. Vd/F of Total Ezetimibe

    pharmacokinetic evaluation

    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

07

Study locations

1 site
  • Korea University Anam Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04762407
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Feb 21, 2021
Start date
Nov 20, 2020
Primary completion
Feb 24, 2021
Completion
Feb 24, 2021
Last update
Jul 14, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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