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CompletedNCT04322266Updated Mar 26, 2020

A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.

A Phase 1 interventional study of HCP1701 and HCP1306 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 2020-03-26.

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

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2018, registered Sep 2019).
Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

Study summary

An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male 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 agree to use medically accepted dual contraceptives up to two months 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

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
61 participants (actual)

Study arms

  • Experimental
    Sequence 1 (Reference-Test)

    Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701

    Drug: HCP1701 · Drug: HCP1306 · Drug: HGP0904 · Drug: HGP0608

  • Experimental
    Sequence 2 (Test-Reference)

    Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608

    Drug: HCP1701 · Drug: HCP1306 · Drug: HGP0904 · Drug: HGP0608

Interventions

  • DrugHCP1701

    Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium

  • DrugHCP1306

    Ezetimibe /Rosuvastatin

  • DrugHGP0904

    Amlodipine

  • DrugHGP0608

    Losartan potassium

06

What researchers measure

Primary outcomes

  1. Cmax of Amlodipine

    Pharmacokinetic evaluation

    Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours

  2. AUClast of Amlodipine

    Pharmacokinetic evaluation

    Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours

  3. Cmax of Losartan

    Pharmacokinetic evaluation

    Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours

  4. AUClast of Losartan

    Pharmacokinetic evaluation

    Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours

  5. Cmax of Rosuvastatin

    Pharmacokinetic evaluation

    Time frame: Day 1,Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours

  6. AUClast of Rosuvastatin

    Pharmacokinetic evaluation

    Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours

  7. Cmax of Free Ezetimibe

    Pharmacokinetic evaluation

    Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours

  8. AUClast of Free Ezetimibe

    Pharmacokinetic evaluation

    Time frame: Day 1, Day15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours

  9. Cmax of EXP3174

    Pharmacokinetic evaluation

    Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours

  10. AUClast of EXP3174

    Pharmacokinetic evaluation

    Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours

Secondary outcomes

  1. Cmax of Total Ezetimibe

    Pharmacokinetic evaluation

    Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours

  2. AUClast of Total Ezetimibe

    Pharmacokinetic evaluation

    Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours

07

Study locations

1 site
  • Korea University Hospital (Anam)
    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 Mar 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04322266
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Mar 26, 2020
Start date
Dec 21, 2018
Primary completion
Feb 13, 2019
Completion
Feb 13, 2019
Last update
Mar 26, 2020

Oversight

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

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