ArthritisPhase 1NCT00749385
A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
A Phase 1 study testing PN 400, EC naproxen plus EC esomeprazole and EC naproxen in people with Arthritis, run by POZEN at 1 site in United States.
Trial summary
A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- PN 400, EC naproxen plus EC esomeprazole and EC naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Oct 2008
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.
Who cannot join
- Standard exclusion criteria for a study of this nature - no significant medical conditions that might affect the interpretation of the PK data or compromise the safety of the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, 4-Way Crossover Study to Evaluate Naproxen and Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400, Enteric-Coated Naproxen 500mg Plus Enteric-Coated Esomeprazole 20mg, Enteric-Coated Naproxen 500mg Alone, and Enteric-Coated Esomeprazole 20mg Alone.
A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.
Read the detailed description
This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated esomeprazole 20mg administered alone.
- Conditions
- Arthritis
- Being tested
- PN 400, EC naproxen plus EC esomeprazole, EC naproxen, EC esomeprazole
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN 400Drug
A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)
EC naproxen plus EC esomeprazoleDrug
Also called EC Naprosyn and Nexium
Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)
EC naproxenDrug
Also called EC Naprosyn
Enteric-coated naproxen tablet (500mg)
EC esomeprazoleDrug
Also called Nexium
Enteric-coated esomeprazole capsule (20mg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PN 400 Receives: Drug: PN 400 |
| 2 | Active comparator | Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg) Receives: Drug: EC naproxen plus EC esomeprazole |
| 3 | Active comparator | Enteric-coated naproxen tablet (500mg) Receives: Drug: EC naproxen |
| 4 | Active comparator | EC esomeprazole capsule (20mg) Receives: Drug: EC esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the single-dose pharmacokinetics and relative bioavailability of esomeprazole in PN 400 (naproxen 500mg / esomeprazole 20mg), the enteric-coated (EC) naproxen 500mg plus EC esomeprazole 20mg and the EC esomeprazole 20mg alone treatments
Measured: 12-72 hour PK assessments
Secondary outcomes (2)
To assess the single-dose pharmacokinetics and relative bioavailability of naproxen in PN 400 (naproxen 500mg / esomeprazole 20mg, the EC naproxen 500mg plus EC esomeprazole 20mg, and the EC naproxen 500mg alone treatments.
Measured: 72-hour PK assessments
To evaluate the safety of each of the single-dose treatments
Measured: Entire study duration (48 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- POZEN
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749385
- Sponsor's protocol ID
- PN400-114
- Status last verified
- Dec 2008
- First submitted
- 5 Sep 2008
- Last updated
- 23 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, 4-Way Crossover Study to Evaluate Naproxen and Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400, Enteric-Coated Naproxen 500mg Plus Enteric-Coated Esomeprazole 20mg, Enteric-Coated Naproxen 500mg Alone, and Enteric-Coated Esomeprazole 20mg Alone.
- ClinicalTrials.gov ID
- NCT00749385
- Acronym / sponsor ID
- PN400-114
- Conditions
- Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- POZENIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Sep 2008 (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 pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.
Detailed description
This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated esomeprazole 20mg administered alone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PN 400PN 400 |
| 2 | Active comparator | Drug: EC naproxen plus EC esomeprazoleEnteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg) |
| 3 | Active comparator | Drug: EC naproxenEnteric-coated naproxen tablet (500mg) |
| 4 | Active comparator | Drug: EC esomeprazoleEC esomeprazole capsule (20mg) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.
Key exclusion criteria (1 listed)
- Standard exclusion criteria for a study of this nature - no significant medical conditions that might affect the interpretation of the PK data or compromise the safety of the subject.
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 |
|---|---|---|
| PN 400A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg) | Drug | 1 |
| EC naproxen plus EC esomeprazoleAlso: EC Naprosyn and NexiumEnteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg) | Drug | 2 |
| EC naproxenAlso: EC NaprosynEnteric-coated naproxen tablet (500mg) | Drug | 3 |
| EC esomeprazoleAlso: NexiumEnteric-coated esomeprazole capsule (20mg) | Drug | 4 |
Primary outcome
To assess the single-dose pharmacokinetics and relative bioavailability of esomeprazole in PN 400 (naproxen 500mg / esomeprazole 20mg), the enteric-coated (EC) naproxen 500mg plus EC esomeprazole 20mg and the EC esomeprazole 20mg alone treatments
Time frame: 12-72 hour PK assessments
2 secondary outcomes
To assess the single-dose pharmacokinetics and relative bioavailability of naproxen in PN 400 (naproxen 500mg / esomeprazole 20mg, the EC naproxen 500mg plus EC esomeprazole 20mg, and the EC naproxen 500mg alone treatments.
Time frame: 72-hour PK assessments
To evaluate the safety of each of the single-dose treatments
Time frame: Entire study duration (48 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 23 Dec 2008.
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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.
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 PN 400, EC naproxen plus EC esomeprazole and EC naproxen in people with Arthritis, run by POZEN at 1 site in United States.
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 23 Dec 2008. 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 United States. 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?
To assess the single-dose pharmacokinetics and relative bioavailability of esomeprazole in PN 400 (naproxen 500mg / esomeprazole 20mg), the enteric-coated (EC) naproxen 500mg plus EC esomeprazole 20mg and the EC esomeprazole 20mg alone treatments (time frame: 12-72 hour PK assessments). 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 23 Dec 2008.