Hypertension(HTN)Phase 1NCT02387554

Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405

A Phase 1 study testing HGP0904, HGP0608 and HGP1405 in people with Hypertension(HTN), 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

The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers 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: Hypertension(HTN)
What is being tested?: HGP0904, HGP0608 and HGP1405
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteSouth Korea
Study dates: Aug 2014to Oct 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

19~45 years old
Healthy men

Who cannot join

Gastroentestinal disease affecting drug absorption

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Bundang Hospital
Bundang, Gyeonggi-do

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, 4-way Crossover Single Dose Clinical Trial to Investigate the Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405 When Administered Alone and in Combination in Healthy Male Volunteers

The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers

Conditions: Hypertension(HTN)
Being tested: HGP0904, HGP0608, HGP1405
Medical subject headings: Hypertension

What participants receive

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

HGP0904Drug
Also called amlodipine
HGP0608Drug
Also called losartan
HGP1405Drug
Also called chlorthalidone

Study groups in NCT02387554
Study group	Role	What they receive
HGP0904+HGP0608+HGP1405	Experimental	amlodipine + losartan + chlorthalidone Receives: Drug: HGP0904; Drug: HGP0608; Drug: HGP1405
HGP0904	Active comparator	amlodipine Receives: Drug: HGP0904
HGP0608	Active comparator	losartan Receives: Drug: HGP0608
HGP1405	Active comparator	chlorthalidone Receives: Drug: HGP1405

What is being measured

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

AUClast
AUClast(Area under the curve to the last measurable concentration)
Measured: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
Cmax
Cmax(maxium concentration)
Measured: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

Secondary outcomes (5)

AUCinf
AUCinf(Area under the curve to infinity)
Measured: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
Tmax
Tmax(Time to maximum concentration)
Measured: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
T1/2
T1/2(Terminal elimination half-life),
Measured: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
CL/F
CL/F(Apparent clearance)
Measured: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
Vz/F
Vz/F(Apparent volume of distribution)
Measured: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

Timeline

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

Aug 2014Oct 2014

First posted13 Mar 2015 (estimated)
Study startAug 2014
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hypertension(HTN)Studies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02387554
Sponsor's protocol ID: HM-ALCH-101
Status last verified: May 2015
First submitted: 17 Dec 2014
Last updated: 12 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Moon SJ, Hong SH, Lim Y, Chung JY. Pharmacokinetic Interaction Among Amlodipine, Losartan, and Chlorthalidone after a Single Oral Administration in Healthy Male Subjects. Clin Pharmacol Drug Dev. 2026 Jan;15(1):e70024. doi: 10.1002/cpdd.70024.
PubMed 41549823

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, 4-way Crossover Single Dose Clinical Trial to Investigate the Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405 When Administered Alone and in Combination in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02387554
Acronym / sponsor ID: HM-ALCH-101
Conditions: Hypertension(HTN)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Collaborators: Seoul National University Bundang Hospital
Study start: Aug 2014
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 13 Mar 2015 (estimated)
Results: Posted 12 Jun 2015

Clinical summary

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

The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
HGP0904+HGP0608+HGP1405	Experimental	Drug: HGP0904, Drug: HGP0608, Drug: HGP1405amlodipine + losartan + chlorthalidone
HGP0904	Active comparator	Drug: HGP0904amlodipine
HGP0608	Active comparator	Drug: HGP0608losartan
HGP1405	Active comparator	Drug: HGP1405chlorthalidone

Who may qualify

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

Key inclusion criteria (2 listed)

19~45 years old
Healthy men

Key exclusion criteria (1 listed)

Gastroentestinal disease affecting drug absorption

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
HGP0904Also: amlodipine	Drug	HGP0904, HGP0904+HGP0608+HGP1405
HGP0608Also: losartan	Drug	HGP0608, HGP0904+HGP0608+HGP1405
HGP1405Also: chlorthalidone	Drug	HGP0904+HGP0608+HGP1405, HGP1405

Primary outcome

AUClast
Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
AUClast(Area under the curve to the last measurable concentration)
Cmax
Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
Cmax(maxium concentration)

5 secondary outcomes

AUCinf
Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
Tmax
Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
T1/2
Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
CL/F
Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
Vz/F
Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

Results and safety

Results posted to the registry on 12 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	10	7
Sequence 2	7	7
Sequence 3	8	6
Sequence 4	8	6

Primary outcome: AUClast

Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr. Geometric mean (90% Confidence Interval). Unit: Ratio(Comb/Alone)

Measure	HGP0904 n = 28	HGP0608 n = 27	HGP1405 n = 27	EXP3174 n = 27
Value	1.0360 (0.9958 to 1.0778)	1.1606 (1.0885 to 1.2375)	1.0266 (0.9752 to 1.0807)	1.0902 (1.0350 to 1.1148)

Primary outcome: Cmax

Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

The sponsor has not posted figures for this outcome.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HGP0904	1 of 28 (3.6%)	0 of 28 (0%)	Not reported
HGP0608	0 of 27 (0%)	0 of 27 (0%)	Not reported
HGP1405	0 of 27 (0%)	0 of 27 (0%)	Not reported
HGP0904+HGP0608+HGP1405	0 of 28 (0%)	2 of 28 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41549823Moon SJ, Hong SH, Lim Y, Chung JY. Pharmacokinetic Interaction Among Amlodipine, Losartan, and Chlorthalidone after a Single Oral Administration in Healthy Male Subjects. Clin Pharmacol Drug Dev. 2026 Jan;15(1):e70024. doi: 10.1002/cpdd.70024.

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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 HGP0904, HGP0608 and HGP1405 in people with Hypertension(HTN), 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 2 inclusion and 1 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 12 Jun 2015. 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?

Yes. Results are posted in the registry (first posted 12 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

AUClast (time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr). The study lists 2 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 NCT02387554, 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 12 Jun 2015.