HealthyPhase 1NVP-1205NCT02289430
to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers
A Phase 1 study testing Crestor+Ezetrol, Ezetrol and Crestor in people with Healthy, run by NVP Healthcare.
Trial summary
The purpose of this study is to compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe. 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?
- Crestor+Ezetrol, Ezetrol and Crestor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Feb 2015
- 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 subjects age between 19 and 45 singed informed consent
Who cannot join
- Hypotension or hypertension has a history of allergy reaction of this drug or other drugs
About this study
Official title: A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers
The purpose of this study is to compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe.
Read the detailed description
drug interaction : rosuvastatin, ezetimibe
- Conditions
- Healthy
- Being tested
- Crestor+Ezetrol, Ezetrol, Crestor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crestor+EzetrolDrug
Also called rosuvatatin+ezetimibe
rosuvastatin+ezetimibe
EzetrolDrug
Also called ezetimibe
ezetimibe
CrestorDrug
Also called rosuvastatin
rosuvastatin
| Study group | Role | What they receive |
|---|---|---|
| Crestor+Ezetrol | Experimental | rosuvastatin+ezetimibe Receives: Drug: Crestor+Ezetrol |
| Ezetrol | Active comparator | ezetimibe Receives: Drug: Ezetrol |
| Crestor | Active comparator | rosuvastatin Receives: Drug: Crestor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve
Measured: 0-24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- NVP Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shin D Seong, M.D., Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289430
- Sponsor's protocol ID
- NVP-1205-02
- Acronym
- NVP-1205
- Status last verified
- Mar 2016
- First submitted
- 9 Nov 2014
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02289430
- Acronym / sponsor ID
- NVP-1205 / NVP-1205-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- NVP HealthcareIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Nov 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 compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe.
Detailed description
drug interaction : rosuvastatin, ezetimibe
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crestor+Ezetrol | Experimental | Drug: Crestor+Ezetrolrosuvastatin+ezetimibe |
| Ezetrol | Active comparator | Drug: Ezetrolezetimibe |
| Crestor | Active comparator | Drug: Crestorrosuvastatin |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects age between 19 and 45 singed informed consent
Key exclusion criteria (1 listed)
- Hypotension or hypertension has a history of allergy reaction of this drug or other drugs
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 |
|---|---|---|
| Crestor+EzetrolAlso: rosuvatatin+ezetimiberosuvastatin+ezetimibe | Drug | Crestor+Ezetrol |
| EzetrolAlso: ezetimibeezetimibe | Drug | Ezetrol |
| CrestorAlso: rosuvastatinrosuvastatin | Drug | Crestor |
Primary outcome
Area Under Curve
Time frame: 0-24h
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 25 Mar 2016.
- 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.
Shin D Seong, M.D. principal investigator
Gachon University Gil Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Crestor+Ezetrol, Ezetrol and Crestor in people with Healthy, run by NVP Healthcare.
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 1 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 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Area Under Curve (time frame: 0-24h). 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 25 Mar 2016.