HealthyPhase 1NCT02140489
Evaluating a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin
A Phase 1 study testing amosartan, rosuvastatin and amosartan and rosuvastatin in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- amosartan, rosuvastatin and amosartan and rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Aug 2014
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male
- Age between 19 and 55
- Signed informed consent
Who cannot join
- Presence of medical history or a concurrent disease
- Has a history of hypersensitivity to IP ingredients
Trial locations and contacts
1 site in 1 country.
Jin-A Jung, Ph.D contact
South Korea1 site, 1 recruiting
- Recruiting
Samgsung Seoul Hospital
Seoul
JaeWook Ko, M.D.
About this study
Official title: An Open-label, Randomized, Single-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin in Healthy Male Volunteers
The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- amosartan, rosuvastatin, amosartan and rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amosartanDrug
Also called amosartan, P.O
rosuvastatinDrug
Also called rosuvastatin, P.O
amosartan and rosuvastatinDrug
Also called amosartan and rosuvastatin, P.O
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | amosartan → rosuvastatin → amosartan and rosuvastatin Receives: Drug: amosartan; Drug: rosuvastatin; Drug: amosartan and rosuvastatin |
| Sequence 2 | Experimental | rosuvastatin → amosartan and rosuvastatin → amosartan Receives: Drug: amosartan; Drug: rosuvastatin; Drug: amosartan and rosuvastatin |
| Sequence 3 | Experimental | amosartan and rosuvastatin → amosartan → rosuvastatin Receives: Drug: amosartan; Drug: rosuvastatin; Drug: amosartan and rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: 0-72h
AUClast
Measured: 0-72h
Secondary outcomes (3)
tmax
Measured: 0-72h
t1/2
Measured: 0-72h
AUCinf
Measured: 0-72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014 (estimated)
- Study completionAug 2014 (estimated)
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JaeWook Ko, M.D., Principal investigator, Samsung Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140489
- Sponsor's protocol ID
- HM-ALRO-101
- Status last verified
- May 2014
- First submitted
- 9 Mar 2014
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02140489
- Acronym / sponsor ID
- HM-ALRO-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 16 May 2014 (estimated)
- 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.
The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: amosartan, Drug: rosuvastatin, Drug: amosartan and rosuvastatinamosartan → rosuvastatin → amosartan and rosuvastatin |
| Sequence 2 | Experimental | Drug: amosartan, Drug: rosuvastatin, Drug: amosartan and rosuvastatinrosuvastatin → amosartan and rosuvastatin → amosartan |
| Sequence 3 | Experimental | Drug: amosartan, Drug: rosuvastatin, Drug: amosartan and rosuvastatinamosartan and rosuvastatin → amosartan → rosuvastatin |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male
- Age between 19 and 55
- Signed informed consent
Key exclusion criteria (2 listed)
- Presence of medical history or a concurrent disease
- Has a history of hypersensitivity to IP ingredients
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 |
|---|---|---|
| amosartanAlso: amosartan, P.O | Drug | Sequence 1, Sequence 2, Sequence 3 |
| rosuvastatinAlso: rosuvastatin, P.O | Drug | Sequence 1, Sequence 2, Sequence 3 |
| amosartan and rosuvastatinAlso: amosartan and rosuvastatin, P.O | Drug | Sequence 1, Sequence 2, Sequence 3 |
Primary outcome
Cmax
Time frame: 0-72h
AUClast
Time frame: 0-72h
3 secondary outcomes
tmax
Time frame: 0-72h
t1/2
Time frame: 0-72h
AUCinf
Time frame: 0-72h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Jin-A Jung, Ph.D contact
JaeWook Ko, M.D. principal investigator
Samsung Seoul Hospital
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 amosartan, rosuvastatin and amosartan and rosuvastatin 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 3 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: status not confirmed, as of the sponsor's last update on 16 May 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-A Jung, Ph.D (jajung@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 0-72h). 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?
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 16 May 2014.