HealthyPhase 1NCT02127320
Investigating the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe
A Phase 1 study testing Rosuvastatin 20mg, Ezetimibe 10mg and Rosuvastatin 20mg + Ezetimibe 10mg 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 investigate the pharmacokinetic drug interactions between Rosuvastatin and Ezetimibe 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?
- Rosuvastatin 20mg, Ezetimibe 10mg and Rosuvastatin 20mg + Ezetimibe 10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Nov 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteer, age 19~45 years
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
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
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe in Healthy Male Subjects
The purpose of this study is to investigate the pharmacokinetic drug interactions between Rosuvastatin and Ezetimibe in Healthy Male Subjects
- Conditions
- Healthy
- Being tested
- Rosuvastatin 20mg, Ezetimibe 10mg, Rosuvastatin 20mg + Ezetimibe 10mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 20mgDrug
Ezetimibe 10mgDrug
Rosuvastatin 20mg + Ezetimibe 10mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Rosuvastatin 20mg → Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg Receives: Drug: Rosuvastatin 20mg; Drug: Ezetimibe 10mg; Drug: Rosuvastatin 20mg + Ezetimibe 10mg |
| Sequence 2 | Experimental | Rosuvastatin 20mg and Ezetimibe 10mg→ Rosuvastatin 20mg → Ezetimibe 10mg Receives: Drug: Rosuvastatin 20mg; Drug: Ezetimibe 10mg; Drug: Rosuvastatin 20mg + Ezetimibe 10mg |
| Sequence 3 | Experimental | Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg → Rosuvastatin 20mg Receives: Drug: Rosuvastatin 20mg; Drug: Ezetimibe 10mg; Drug: Rosuvastatin 20mg + Ezetimibe 10mg |
| Sequence 4 | Experimental | Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg → Rosuvastatin 20mg Receives: Drug: Rosuvastatin 20mg; Drug: Ezetimibe 10mg; Drug: Rosuvastatin 20mg + Ezetimibe 10mg |
| Sequence 5 | Experimental | Ezetimibe 10mg → Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg Receives: Drug: Rosuvastatin 20mg; Drug: Ezetimibe 10mg; Drug: Rosuvastatin 20mg + Ezetimibe 10mg |
| Sequence 6 | Experimental | Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg Receives: Drug: Rosuvastatin 20mg; Drug: Ezetimibe 10mg; Drug: Rosuvastatin 20mg + Ezetimibe 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rosuvastatin AUCτ,ss
Measured: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Rosuvastatin Cmax,ss
Measured: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Ezetimibe Cmax,ss
Measured: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Ezetimibe AUCτ,ss
Measured: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Secondary outcomes (4)
Rosuvastatin Tmax,ss
Measured: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Rosuvastatin t1/2β
Measured: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Ezetimibe Tmax,ss
Measured: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Ezetimibe t1/2β
Measured: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionNov 2014
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyeong-Seok Lim, MD PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127320
- Sponsor's protocol ID
- HM-ROZE-101
- Status last verified
- Jul 2014
- First submitted
- 29 Apr 2014
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02127320
- Acronym / sponsor ID
- HM-ROZE-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Apr 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 investigate the pharmacokinetic drug interactions between Rosuvastatin and Ezetimibe in Healthy Male Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Rosuvastatin 20mg, Drug: Ezetimibe 10mg, Drug: Rosuvastatin 20mg + Ezetimibe 10mgRosuvastatin 20mg → Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg |
| Sequence 2 | Experimental | Drug: Rosuvastatin 20mg, Drug: Ezetimibe 10mg, Drug: Rosuvastatin 20mg + Ezetimibe 10mgRosuvastatin 20mg and Ezetimibe 10mg→ Rosuvastatin 20mg → Ezetimibe 10mg |
| Sequence 3 | Experimental | Drug: Rosuvastatin 20mg, Drug: Ezetimibe 10mg, Drug: Rosuvastatin 20mg + Ezetimibe 10mgEzetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg → Rosuvastatin 20mg |
| Sequence 4 | Experimental | Drug: Rosuvastatin 20mg, Drug: Ezetimibe 10mg, Drug: Rosuvastatin 20mg + Ezetimibe 10mgRosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg → Rosuvastatin 20mg |
| Sequence 5 | Experimental | Drug: Rosuvastatin 20mg, Drug: Ezetimibe 10mg, Drug: Rosuvastatin 20mg + Ezetimibe 10mgEzetimibe 10mg → Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg |
| Sequence 6 | Experimental | Drug: Rosuvastatin 20mg, Drug: Ezetimibe 10mg, Drug: Rosuvastatin 20mg + Ezetimibe 10mgRosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteer, age 19~45 years
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
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
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
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 |
|---|---|---|
| Rosuvastatin 20mg | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Ezetimibe 10mg | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Rosuvastatin 20mg + Ezetimibe 10mg | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Rosuvastatin AUCτ,ss
Time frame: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Rosuvastatin Cmax,ss
Time frame: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Ezetimibe Cmax,ss
Time frame: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Ezetimibe AUCτ,ss
Time frame: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
4 secondary outcomes
Rosuvastatin Tmax,ss
Time frame: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Rosuvastatin t1/2β
Time frame: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Ezetimibe Tmax,ss
Time frame: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Ezetimibe t1/2β
Time frame: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
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 12 Oct 2016.
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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.
Hyeong-Seok Lim, MD PhD principal investigator
Asan Medical Center
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 Rosuvastatin 20mg, Ezetimibe 10mg and Rosuvastatin 20mg + Ezetimibe 10mg 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: finished, as of the sponsor's last update on 12 Oct 2016. 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?
Rosuvastatin AUCτ,ss (time frame: 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h). The study lists 4 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 12 Oct 2016.