Healthy VolunteerPhase 1NCT00761501
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E
A Phase 1 study testing PN400, Naproxen (Proxen S) and Naproxen (Naprosyn E) in people with Healthy Volunteer, run by AstraZeneca at 2 sites in Sweden.
Trial summary
The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- PN400, Naproxen (Proxen S) and Naproxen (Naprosyn E)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesSweden
- Study dates
- Sep 2008to Dec 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
- Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
- Clinically normal physical exams and laboratory measurements
Who cannot join
- Subject has received another investigational drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study
- Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
- Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
- Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Phase I, Open-label, Randomized, 3-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E in Healthy Volunteers
The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.
- Conditions
- Healthy Volunteer
- Being tested
- PN400, Naproxen (Proxen S), Naproxen (Naprosyn E)
- Keywords
- Phase I, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN400Drug
Also called VIMOVO™
Oral
Naproxen (Proxen S)Drug
Also called Proxen S
Oral
Naproxen (Naprosyn E)Drug
Also called Naprosyn E
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PN400 |
| 2 | Active comparator | Not described Receives: Drug: Naproxen (Proxen S) |
| 3 | Active comparator | Not described Receives: Drug: Naproxen (Naprosyn E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Measured: pre-dose and multiple times post-dose
Secondary outcomes (1)
Safety
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Sostek, MD, Study director, AstraZenecaAslak Rautio, MD, Principal investigator, Quintiles HermelinenWolfgang Kuhn, MD, Principal investigator, Quintiles Phase I Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761501
- Sponsor's protocol ID
- D1120C00001
- Status last verified
- Dec 2010
- First submitted
- 26 Sep 2008
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-label, Randomized, 3-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00761501
- Acronym / sponsor ID
- D1120C00001
- Conditions
- Healthy Volunteer
- Keywords
- Phase I, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 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.
The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PN400 |
| 2 | Active comparator | Drug: Naproxen (Proxen S) |
| 3 | Active comparator | Drug: Naproxen (Naprosyn E) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
- Clinically normal physical exams and laboratory measurements
Key exclusion criteria (4 listed)
- Subject has received another investigational drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study
- Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
- Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
- Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit
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 |
|---|---|---|
| PN400Also: VIMOVO™Oral | Drug | 1 |
| Naproxen (Proxen S)Also: Proxen SOral | Drug | 2 |
| Naproxen (Naprosyn E)Also: Naprosyn EOral | Drug | 3 |
Primary outcome
Pharmacokinetics
Time frame: pre-dose and multiple times post-dose
1 secondary outcome
Safety
Time frame: Throughout study
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 9 Dec 2010.
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Screening Protocol
Pain
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.
Mark Sostek, MD study director
AstraZeneca
Aslak Rautio, MD principal investigator
Quintiles Hermelinen
Wolfgang Kuhn, MD principal investigator
Quintiles Phase I Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PN400, Naproxen (Proxen S) and Naproxen (Naprosyn E) in people with Healthy Volunteer, run by AstraZeneca at 2 sites in Sweden.
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 2 inclusion and 4 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 9 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Pharmacokinetics (time frame: pre-dose and multiple times post-dose). 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 9 Dec 2010.