HealthyPhase 1NCT01501435
To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra
A Phase 1 study testing CJ-30039 and fenofibric acid in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CJ-30039 and fenofibric acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Jun 2012
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers in the age between 20 and 55 years old
- BMI(Body Mass Index) in the range of 18.5 to 25kg/m2
- Subject with no history of any significant chronic disease
Who cannot join
- History of clinically significant allergies, including fenofibric acid or Fenofibrate
- History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
- History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
- Clinical laboratory test values are outside the accepted normal range
- AST(ASpartate Transaminase), ALT(ALanine Transaminase)( > 1.25 times to normal range
- Total bilirubin > 1.5 times to normal range
Show all 20Show fewer
- BUN(Blood Urea Nitrogen) > 25 mg/dL or Creatinine > 1.4 mg/dL
- CK(Creatine Kinase) > 1.25 times to normal range
- Estimated GFR(Glomerular Filtration Rate) < 80 mL/min/1.73m2
- Clinically significant vital sign
- SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg
- DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg
- History of drug abuse or positive urine screen for drugs
- History of caffeine, alcohol, smoking abuse
- caffeine > 5 cups/day
- alcohol > 201g/week
- smoking > 10 cigarettes/day
- Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing
- Participated in a previous clinical trial within 60 days prior to dosing
- Donated blood within 60 days prior to dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study to Compare the Pharmacokinetics of CJ-30039 and Lipidil Supra and to Investigate Food-effect on Pharmacokinetics of CJ-30039
To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra
Read the detailed description
Study objectives
- To compare the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra after a single oral administration in healthy male volunteers.
- To evaluate the food-effect on pharmacokinetics of CJ-30039 after a single oral administration in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- CJ-30039, fenofibric acid
- Keywords
- Safety, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-30039Drug
Also called Incrementally Modified Drugs of fenofibric acid
single dose
fenofibric acidDrug
Also called Greencross Lipidil Supra 160mg
single dose
| Study group | Role | What they receive |
|---|---|---|
| CJ-30039 | Experimental | Incrementally Modified Drugs of fenofibric acid Receives: Drug: CJ-30039 |
| fenofibric acid | Active comparator | Greencross Lipidil Supra 160mg Receives: Drug: fenofibric acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of fenofibric acid
Measured: up to 48 hours
Secondary outcomes (1)
Area under the plasma concentration versus time curve (AUC) of fenofibric acid
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2012
- Study completionJun 2012
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 HK inno.N CorporationThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-su Park, MD PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501435
- Sponsor's protocol ID
- CJ_FEN_101
- Status last verified
- Dec 2016
- First submitted
- 24 Dec 2011
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study to Compare the Pharmacokinetics of CJ-30039 and Lipidil Supra and to Investigate Food-effect on Pharmacokinetics of CJ-30039
- ClinicalTrials.gov ID
- NCT01501435
- Acronym / sponsor ID
- CJ_FEN_101
- Conditions
- Healthy
- Keywords
- Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Dec 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.
To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra
Detailed description
Study objectives
- To compare the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra after a single oral administration in healthy male volunteers.
- To evaluate the food-effect on pharmacokinetics of CJ-30039 after a single oral administration in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CJ-30039 | Experimental | Drug: CJ-30039Incrementally Modified Drugs of fenofibric acid |
| fenofibric acid | Active comparator | Drug: fenofibric acidGreencross Lipidil Supra 160mg |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male volunteers in the age between 20 and 55 years old
- BMI(Body Mass Index) in the range of 18.5 to 25kg/m2
- Subject with no history of any significant chronic disease
Key exclusion criteria (20 listed)
- History of clinically significant allergies, including fenofibric acid or Fenofibrate
- History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
- History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
- Clinical laboratory test values are outside the accepted normal range
- Estimated GFR(Glomerular Filtration Rate) < 80 mL/min/1.73m2
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 |
|---|---|---|
| CJ-30039Also: Incrementally Modified Drugs of fenofibric acidsingle dose | Drug | CJ-30039 |
| fenofibric acidAlso: Greencross Lipidil Supra 160mgsingle dose | Drug | fenofibric acid |
Primary outcome
Peak Plasma Concentration (Cmax) of fenofibric acid
Time frame: up to 48 hours
1 secondary outcome
Area under the plasma concentration versus time curve (AUC) of fenofibric acid
Time frame: up to 48 hours
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 2 Jan 2017.
- 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.
Min-su Park, MD PhD principal investigator
Severance 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 CJ-30039 and fenofibric acid in people with Healthy, run by HK inno.N 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 20 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 2 Jan 2017. 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?
Peak Plasma Concentration (Cmax) of fenofibric acid (time frame: up to 48 hours). 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 2 Jan 2017.