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HealthyPhase 1NCT04322266

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 study testing HCP1701, HCP1306 and HGP0904 in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
HCP1701, HCP1306 and HGP0904
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteSouth Korea
Study dates
21 Dec 2018to 13 Feb 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Hospital (Anam)

    Seoul

Other trials in South Korea

About this study

Official title: 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

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

Conditions
Healthy
Being tested
HCP1701, HCP1306, HGP0904, HGP0608

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HCP1701Drug

    Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium

  • HCP1306Drug

    Ezetimibe /Rosuvastatin

  • HGP0904Drug

    Amlodipine

  • HGP0608Drug

    Losartan potassium

Study groups in NCT04322266
Study groupRoleWhat they receive
Sequence 1 (Reference-Test)ExperimentalPeriod1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701
Receives: Drug: HCP1701; Drug: HCP1306; Drug: HGP0904; Drug: HGP0608
Sequence 2 (Test-Reference)ExperimentalPeriod1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608
Receives: Drug: HCP1701; Drug: HCP1306; Drug: HGP0904; Drug: HGP0608

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of Amlodipine

    Pharmacokinetic evaluation

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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 (2)

  1. Cmax of Total Ezetimibe

    Pharmacokinetic evaluation

    Measured: 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2020
  2. Study start21 Dec 2018
  3. Primary completion13 Feb 2019
  4. Study completion13 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04322266
Sponsor's protocol ID
HM-AMOS-102
Status last verified
Mar 2020
First submitted
9 Sep 2019
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park JW, Chung H, Kim JM, Kim NY, Hong SH, Kim KA, Park JY. Pharmacokinetics of a Fixed-Dose Combination Product of Amlodipine, Losartan, Ezetimibe, and Rosuvastatin and Its Comparison with Co-administration of Four Individual Components in Healthy Participants. Drugs R D. 2024 Jun;24(2):179-186. doi: 10.1007/s40268-024-00460-y. Epub 2024 May 22.

    PubMed 38775910

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HCP1701, HCP1306 and HGP0904 in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of Amlodipine (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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04322266, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.

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