HealthyPhase 1NCT01964365
Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and Fenofibric Acid in Healthy Male Volunteers
A Phase 1 study testing Cresto 20mg, Fenofibric acid 135mg and Cresto 20mg, Fenofibric acid 135mg in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and fenofibric acid in healthy adult 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?
- Cresto 20mg, Fenofibric acid 135mg and Cresto 20mg, Fenofibric acid 135mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Dec 2013
- 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 adult male volunteers aged 19 to 45 years
- A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
- A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints
Who cannot join
- A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
- A subject who shows the following result in clinical laboratory test
- AST, ALT > 1.25 times of the upper limit of normal range
- PR ≥ 210 msec
- QRS ≥ 120 msec
- QT ≥ 500 msec
- QTcF ≥ 500 msec
- Subject who has taken other clinical medication from another clinical trial within 60-day period prior to the first administration of the study medication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Inje University College of Medicine Busan Paik Hospital
Busan
About this study
Official title: An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Rosuvastatin and Fenofibric Acid in Healthy Adult Subjects
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and fenofibric acid in healthy adult subjects
- Conditions
- Healthy
- Being tested
- Cresto 20mg, Fenofibric acid 135mg, Cresto 20mg, Fenofibric acid 135mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cresto 20mgDrug
tablet, rosuvastatin 20mg
Fenofibric acid 135mgDrug
capsule, fenofibric acid 135mg
Cresto 20mg, Fenofibric acid 135mgDrug
rosuvastatin 20mg, Fenofibric acid 135mg
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | multiple dose of Rosuvastatin 20mg Receives: Drug: Cresto 20mg |
| Fenofibric acid | Experimental | multiple dose of Fenofibric acid 135mg Receives: Drug: Fenofibric acid 135mg |
| Rosuvastatin + Fenofibric acid | Experimental | multiple dose of the combination of Rosuvastatin 20mg and Fenofibric acid 135mg Receives: Drug: Cresto 20mg, Fenofibric acid 135mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
AUCtau
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Secondary outcomes (5)
Cmin
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Tmax
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
CL/F
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
T1/2
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Metabolic Ratio
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
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 Daewoong Pharmaceutical Co. LTD.The 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae-Gook Shin, Professor, Principal investigator, BUSAN PAIK HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964365
- Sponsor's protocol ID
- DW_DWJ1330001
- Status last verified
- Oct 2013
- First submitted
- 15 Oct 2013
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Rosuvastatin and Fenofibric Acid in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01964365
- Acronym / sponsor ID
- DW_DWJ1330001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Oct 2013 (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 pharmacokinetics profile and drug-drug interaction between rosuvastatin and fenofibric acid in healthy adult subjects
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Cresto 20mgmultiple dose of Rosuvastatin 20mg |
| Fenofibric acid | Experimental | Drug: Fenofibric acid 135mgmultiple dose of Fenofibric acid 135mg |
| Rosuvastatin + Fenofibric acid | Experimental | Drug: Cresto 20mg, Fenofibric acid 135mgmultiple dose of the combination of Rosuvastatin 20mg and Fenofibric acid 135mg |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult male volunteers aged 19 to 45 years
- A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
- A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints
Key exclusion criteria (8 listed)
- A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
- A subject who shows the following result in clinical laboratory test
- Subject who has taken other clinical medication from another clinical trial within 60-day period prior to the first administration of the study medication
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 |
|---|---|---|
| Cresto 20mgtablet, rosuvastatin 20mg | Drug | Rosuvastatin |
| Fenofibric acid 135mgcapsule, fenofibric acid 135mg | Drug | Fenofibric acid |
| Cresto 20mg, Fenofibric acid 135mgrosuvastatin 20mg, Fenofibric acid 135mg | Drug | Rosuvastatin + Fenofibric acid |
Primary outcome
Cmax
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
AUCtau
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
5 secondary outcomes
Cmin
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Tmax
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
CL/F
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
T1/2
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Metabolic Ratio
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
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 13 Feb 2014.
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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.
Jae-Gook Shin, Professor principal investigator
BUSAN PAIK 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 Cresto 20mg, Fenofibric acid 135mg and Cresto 20mg, Fenofibric acid 135mg in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. 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 8 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 13 Feb 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?
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 (time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods). 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 13 Feb 2014.