HyperlipidemiaPhase 1NCT01353404
Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)
A Phase 1 study testing Sequence 1, Sequence 2 and Seqeunce 3 in people with Hyperlipidemia, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Sequence 1, Sequence 2 and Seqeunce 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Aug 2011
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 20-50 years of age
- Weight more than 55kg and within ±20% IBW(Ideal Body Weight)
- Voluntary written informed consent
Who cannot join
- History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease
- Drug allergies to fenofibrate
- Recent history or evidence of drug abuse
- Recent participation(within 2months) in other clinical studies
- Recent donation of blood(within 2months) or plasma(within 1months)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Research Institute, Seoul National University Hospital
Seoul
About this study
Official title: Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg) in Normal Healthy Subjects
The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.
- Conditions
- Hyperlipidemia
- Being tested
- Sequence 1, Sequence 2, Seqeunce 3, Sequence 4, Sequence 5
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequence 1Drug
fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral
Sequence 2Drug
fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral
Seqeunce 3Drug
fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral
Sequence 4Drug
fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral
Sequence 5Drug
fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral
Sequence 6Drug
fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral
| Study group | Role | What they receive |
|---|---|---|
| fenofibrate 65mg, fed condition, per oral | Experimental | Not described Receives: Drug: Sequence 1; Drug: Sequence 2; Drug: Seqeunce 3; Drug: Sequence 4; Drug: Sequence 5; Drug: Sequence 6 |
| fenofibrate 65mg, fasting condition, per oral | Experimental | Not described Receives: Drug: Sequence 1; Drug: Sequence 2; Drug: Seqeunce 3; Drug: Sequence 4; Drug: Sequence 5; Drug: Sequence 6 |
| fenofibrate 160mg, fed condition, per oral | Active comparator | Not described Receives: Drug: Sequence 1; Drug: Sequence 2; Drug: Seqeunce 3; Drug: Sequence 4; Drug: Sequence 5; Drug: Sequence 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg)
Measured: 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, M.D., Ph.D., M.B.A., Principal investigator, Clinical Research Institute, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353404
- Sponsor's protocol ID
- SYO0805
- Status last verified
- Dec 2012
- First submitted
- 12 May 2011
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg) in Normal Healthy Subjects
- ClinicalTrials.gov ID
- NCT01353404
- Acronym / sponsor ID
- SYO0805
- Conditions
- Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 May 2011 (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 bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fenofibrate 65mg, fed condition, per oral | Experimental | Drug: Sequence 1, Drug: Sequence 2, Drug: Seqeunce 3, Drug: Sequence 4, Drug: Sequence 5, Drug: Sequence 6 |
| fenofibrate 65mg, fasting condition, per oral | Experimental | Drug: Sequence 1, Drug: Sequence 2, Drug: Seqeunce 3, Drug: Sequence 4, Drug: Sequence 5, Drug: Sequence 6 |
| fenofibrate 160mg, fed condition, per oral | Active comparator | Drug: Sequence 1, Drug: Sequence 2, Drug: Seqeunce 3, Drug: Sequence 4, Drug: Sequence 5, Drug: Sequence 6 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults 20-50 years of age
- Weight more than 55kg and within ±20% IBW(Ideal Body Weight)
- Voluntary written informed consent
Key exclusion criteria (5 listed)
- History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease
- Drug allergies to fenofibrate
- Recent history or evidence of drug abuse
- Recent participation(within 2months) in other clinical studies
- Recent donation of blood(within 2months) or plasma(within 1months)
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 |
|---|---|---|
| Sequence 1fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral | Drug | fenofibrate 160mg, fed condition, per oral, fenofibrate 65mg, fasting condition, per oral, fenofibrate 65mg, fed condition, per oral |
| Sequence 2fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral | Drug | fenofibrate 160mg, fed condition, per oral, fenofibrate 65mg, fasting condition, per oral, fenofibrate 65mg, fed condition, per oral |
| Seqeunce 3fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral | Drug | fenofibrate 160mg, fed condition, per oral, fenofibrate 65mg, fasting condition, per oral, fenofibrate 65mg, fed condition, per oral |
| Sequence 4fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral | Drug | fenofibrate 160mg, fed condition, per oral, fenofibrate 65mg, fasting condition, per oral, fenofibrate 65mg, fed condition, per oral |
| Sequence 5fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral | Drug | fenofibrate 160mg, fed condition, per oral, fenofibrate 65mg, fasting condition, per oral, fenofibrate 65mg, fed condition, per oral |
| Sequence 6fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral | Drug | fenofibrate 160mg, fed condition, per oral, fenofibrate 65mg, fasting condition, per oral, fenofibrate 65mg, fed condition, per oral |
Primary outcome
Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg)
Time frame: 23 days
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 18 Dec 2012.
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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.
Kyung-Sang Yu, M.D., Ph.D., M.B.A. principal investigator
Clinical Research Institute, Seoul National University 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 Sequence 1, Sequence 2 and Seqeunce 3 in people with Hyperlipidemia, run by Samyang Biopharmaceuticals Corporation 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 5 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 18 Dec 2012. 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?
Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg) (time frame: 23 days). 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 18 Dec 2012.