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CompletedNCT04252872Updated Feb 5, 2020

Pharmacokinetics of HCP1401 and Co-administration of HCP0605, HGP1405 in Healthy Male Volunteers

A Phase 1 interventional study of HCP0605 and HGP1405 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 2020-02-05.

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

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

Study summary

A randomized, open-label, oral single dose, two-way crossover clinical trial to compare the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605 and HGP1405 in healthy male volunteers

Read the detailed description

The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605, HGP1405 in healthy male volunteers

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. Healthy male volunteer, age 19\~45 years
  2. Weight is not less than 55kg, no more than 90kg and Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
  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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric 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
64 participants (actual)

Study arms

  • Experimental
    Sequence A

    Period 1 : HCP0605+HGP1405 Period 2 : HCP1401

    Drug: HCP0605 · Drug: HGP1405 · Drug: HCP1401

  • Experimental
    Sequence B

    Period 1 : HCP1401 Period 2 : HCP0605+HGP1405

    Drug: HCP0605 · Drug: HGP1405 · Drug: HCP1401

Interventions

  • DrugHCP0605
  • DrugHGP1405
  • DrugHCP1401
06

What researchers measure

Primary outcomes

  1. AUClast

    Area under the plasma concentration versus time curve

    Time frame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose

  2. Cmax

    Peak Plasma Concentration

    Time frame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose

Secondary outcomes

  1. AUCinf

    Time frame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose

  2. Tmax

    Time frame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose

  3. T1/2

    Time frame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose

  4. Cl/F

    Time frame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose

  5. Vz/F

    Time frame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04252872
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Feb 5, 2020
Start date
Aug 2015
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Feb 5, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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