HealthyPhase 1NCT01776697
Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR TID and Pelubiprofen SR (as a Pelubiprofen 90 mg) Tablet QD in Healthy Subjects
A Phase 1 study testing pelubiprofen (30mg) tablet IR and pelubiprofen SR (as a pelubiprofen 90 mg) tablet in people with Healthy, run by Daewon Pharmaceutical Co., Ltd..
Trial summary
A randomized, open-labeled, comparative 3-way crossover study to compare the pharmacokinetic characteristics and food effect of pelubiprofen (30mg) tablet IR TID and pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD in healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- pelubiprofen (30mg) tablet IR and pelubiprofen SR (as a pelubiprofen 90 mg) tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2012to Apr 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult Healthy males aged 20~45 years
- weight over 45 kg, ideal body weight ±20%[Ideal weight] = [Height(cm)-100] X 0.9
- Subjects who voluntarily agreed with written consent
Who cannot join
- Patients with acute disorder within 28 days before clinical trial drugs administration
- History of disorders(inflammatory GI tract disease, stomach ulcer, gastrectomy, liver disease) which can affect ADME of drugs
- Patients with active GI tract, cardiovascular, respiratory, renal, endocrinal, haematological, central nerval, psychiatric disease or malignant tumor
About this study
Official title: A Randomized, Open-labeled, Comparative 3-way Crossover Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR TID and Pelubiprofen SR (as a Pelubiprofen 90 mg) Tablet QD in Healthy Subjects
A randomized, open-labeled, comparative 3-way crossover study to compare the pharmacokinetic characteristics and food effect of pelubiprofen (30mg) tablet IR TID and pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD in healthy subjects.
- Conditions
- Healthy
- Being tested
- pelubiprofen (30mg) tablet IR, pelubiprofen SR (as a pelubiprofen 90 mg) tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelubiprofen (30mg) tablet IRDrug
pelubiprofen SR (as a pelubiprofen 90 mg) tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| pelubiprofen (30mg) tablet IR TID, fasting | Active comparator | Not described Receives: Drug: pelubiprofen (30mg) tablet IR |
| pelubiprofen (30mg) tablet IR TID, fed | Active comparator | Not described Receives: Drug: pelubiprofen (30mg) tablet IR |
| pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD | Experimental | Not described Receives: Drug: pelubiprofen SR (as a pelubiprofen 90 mg) tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of pelubiprofen(30mg) tablet IR TID
Measured: 0, 1, 2, 8, 9, 15, 16, 22 day
AUC of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD
Measured: 0, 1, 2, 8, 9, 15, 16, 22 day
Cmax of pelubiprofen(30mg) tablet IR TID
Measured: 0, 1, 2, 8, 9, 15, 16, 22 day
Cmax of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD
Measured: 0, 1, 2, 8, 9, 15, 16, 22 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionApr 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.
- 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
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776697
- Sponsor's protocol ID
- DW330SR-1001(Ver2.2)
- Status last verified
- Jan 2013
- First submitted
- 22 Jan 2013
- Last updated
- 28 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-labeled, Comparative 3-way Crossover Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR TID and Pelubiprofen SR (as a Pelubiprofen 90 mg) Tablet QD in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01776697
- Acronym / sponsor ID
- DW330SR-1001(Ver2.2)
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Jan 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.
A randomized, open-labeled, comparative 3-way crossover study to compare the pharmacokinetic characteristics and food effect of pelubiprofen (30mg) tablet IR TID and pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD in healthy subjects.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pelubiprofen (30mg) tablet IR TID, fasting | Active comparator | Drug: pelubiprofen (30mg) tablet IR |
| pelubiprofen (30mg) tablet IR TID, fed | Active comparator | Drug: pelubiprofen (30mg) tablet IR |
| pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD | Experimental | Drug: pelubiprofen SR (as a pelubiprofen 90 mg) tablet |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult Healthy males aged 20~45 years
- weight over 45 kg, ideal body weight ±20%[Ideal weight] = [Height(cm)-100] X 0.9
- Subjects who voluntarily agreed with written consent
Key exclusion criteria (3 listed)
- Patients with acute disorder within 28 days before clinical trial drugs administration
- History of disorders(inflammatory GI tract disease, stomach ulcer, gastrectomy, liver disease) which can affect ADME of drugs
- Patients with active GI tract, cardiovascular, respiratory, renal, endocrinal, haematological, central nerval, psychiatric disease or malignant tumor
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 |
|---|---|---|
| pelubiprofen (30mg) tablet IR | Drug | pelubiprofen (30mg) tablet IR TID, fasting, pelubiprofen (30mg) tablet IR TID, fed |
| pelubiprofen SR (as a pelubiprofen 90 mg) tablet | Drug | pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD |
Primary outcome
AUC of pelubiprofen(30mg) tablet IR TID
Time frame: 0, 1, 2, 8, 9, 15, 16, 22 day
AUC of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD
Time frame: 0, 1, 2, 8, 9, 15, 16, 22 day
Cmax of pelubiprofen(30mg) tablet IR TID
Time frame: 0, 1, 2, 8, 9, 15, 16, 22 day
Cmax of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD
Time frame: 0, 1, 2, 8, 9, 15, 16, 22 day
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 28 Jan 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pelubiprofen (30mg) tablet IR and pelubiprofen SR (as a pelubiprofen 90 mg) tablet in people with Healthy, run by Daewon Pharmaceutical Co., Ltd..
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 3 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 28 Jan 2013. 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?
AUC of pelubiprofen(30mg) tablet IR TID (time frame: 0, 1, 2, 8, 9, 15, 16, 22 day). 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 28 Jan 2013.