HealthyPhase 1NCT04081844

A Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608, and HCP1306 in Healthy Male Subjects.

A Phase 1 study testing HCP1306, HGP0904 and HGP0608 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, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions between HGP0904, HGP0608 and HCP1306 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?: HCP1306, HGP0904 and HGP0608
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteSouth Korea
Study dates: 3 May 2018to 28 Jun 2018
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, Multiple Dose, Fixed-sequence, 3-period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608 and HCP1306 in Healthy Male Subjects

An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions between HGP0904, HGP0608 and HCP1306 in Healthy Male Subjects

Conditions: Healthy
Being tested: HCP1306, HGP0904, HGP0608

What participants receive

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

HCP1306Drug
Ezetimibe 10mg / Rosuvastatin 20mg (Rosuzet)
HGP0904Drug
Amlodipine 5mg(Norvasc)
HGP0608Drug
Losartan 100mg(Cozaar)

Study groups in NCT04081844
Study group	Role	What they receive
Fixed-Sequence	Experimental	Period 1: Fasted state+HCP1306, Period 2: Fasted state+HGP0904+HGP0608, Period 3: Fasted state+HCP1306+HGP0904+HGP0608 Receives: Drug: HCP1306; Drug: HGP0904; Drug: HGP0608

What is being measured

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

Cmax,ss of Amlodipine
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
AUCtau of Amlodipine
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmax,ss of Losartan
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
AUCtau of Losartan
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmax,ss of EXP3174
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
AUCtau of EXP3174
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmax,ss of Rosuvastatin
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
AUCtau of Rosuvastatin
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmax,ss of Free Ezetimibe
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
AUCtau of Free Ezetimibe
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmax,ss of Total Ezetimibe
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
AUCtau of Total Ezetimibe
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

Secondary outcomes (18)

Cmin,ss of Amlodipine
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T max,ss of Amlodipine
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of Amlodipine
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmin,ss of Losartan
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T max,ss of Losartan
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of Losartan
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmin,ss of EXP3174
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T max,ss of EXP3174
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of EXP3174
Pharmacokinetic evaluation
Measured: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmin,ss of Rosuvastatin
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T max,ss of Rosuvastatin
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of Rosuvastatin
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmin,ss of Free Ezetimibe
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Tmax,ss of Free Ezetimibe
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of Free Ezetimibe
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmin,ss of Total Ezetimibe
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Tmax,ss of Total Ezetimibe
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of Total Ezetimibe
Pharmacokinetic evaluation
Measured: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

Timeline

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

3 May 201828 Jun 2018

First posted9 Sep 2019
Study start3 May 2018
Primary completion28 Jun 2018
Study completion28 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Intervention model: Sequential
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04081844
Sponsor's protocol ID: HM-AMOS-101
Status last verified: Sep 2019
First submitted: 2 Sep 2019
Last updated: 9 Sep 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multiple Dose, Fixed-sequence, 3-period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608 and HCP1306 in Healthy Male Subjects
ClinicalTrials.gov ID: NCT04081844
Acronym / sponsor ID: HM-AMOS-101
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Study start: 3 May 2018 (actual)
Primary completion: 28 Jun 2018 (actual)
Study completion: 28 Jun 2018 (actual)
First posted: 9 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions between HGP0904, HGP0608 and HCP1306 in Healthy Male Subjects

Study design

Primary purpose: Treatment
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fixed-Sequence	Experimental	Drug: HCP1306, Drug: HGP0904, Drug: HGP0608Period 1: Fasted state+HCP1306, Period 2: Fasted state+HGP0904+HGP0608, Period 3: Fasted state+HCP1306+HGP0904+HGP0608

Who may qualify

Ages: 19 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HCP1306Ezetimibe 10mg / Rosuvastatin 20mg (Rosuzet)	Drug	Fixed-Sequence
HGP0904Amlodipine 5mg(Norvasc)	Drug	Fixed-Sequence
HGP0608Losartan 100mg(Cozaar)	Drug	Fixed-Sequence

Primary outcome

Cmax,ss of Amlodipine
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation
AUCtau of Amlodipine
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation
Cmax,ss of Losartan
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation
AUCtau of Losartan
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation
Cmax,ss of EXP3174
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation
AUCtau of EXP3174
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation
Cmax,ss of Rosuvastatin
Time frame: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation
AUCtau of Rosuvastatin
Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation
Cmax,ss of Free Ezetimibe
Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation
AUCtau of Free Ezetimibe
Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation
Cmax,ss of Total Ezetimibe
Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation
AUCtau of Total Ezetimibe
Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Pharmacokinetic evaluation

18 secondary outcomes

Cmin,ss of Amlodipine
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T max,ss of Amlodipine
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of Amlodipine
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmin,ss of Losartan
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T max,ss of Losartan
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of Losartan
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmin,ss of EXP3174
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T max,ss of EXP3174
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of EXP3174
Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmin,ss of Rosuvastatin
Time frame: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T max,ss of Rosuvastatin
Time frame: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of Rosuvastatin
Time frame: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmin,ss of Free Ezetimibe
Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Tmax,ss of Free Ezetimibe
Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of Free Ezetimibe
Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Cmin,ss of Total Ezetimibe
Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Tmax,ss of Total Ezetimibe
Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
T1/2 of Total Ezetimibe
Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HCP1306, HGP0904 and HGP0608 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 9 Sep 2019. 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,ss of Amlodipine (time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour). The study lists 12 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 NCT04081844.

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 9 Sep 2019.