Healthy VolunteersPhase 1NCT01331993
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
A Phase 1 study testing VIMOVO (AstraZeneca), VIMOVO (Patheon) and Marketed enteric-coated naproxen formulation in people with Healthy Volunteers and Bioequivalence, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen formulation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Bioequivalence
- What is being tested?
- VIMOVO (AstraZeneca), VIMOVO (Patheon) and Marketed enteric-coated naproxen formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Oct 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteer, aged 18 - 55 years (inclusive)
- Female volunteers must be non-pregnant and non-lactating and have a negative urine pregnancy test result prior to enrolment into the study.
- Female volunteers of childbearing potential must be using appropriate birth control during the entire duration of the study
- Body mass index of = 19 to =30 kg/m2 (inclusive) and weights of = 50 to = 100 kg (inclusive)
Who cannot join
- Volunteer who is likely to have unrecognized cardiovascular or cerebrovascular disease, based on history or risk factors, or who has a clinical significant ECG finding at screening
- Uncontrolled hypertension defined as resting systolic pressure >140 mmHg or diastolic pressure >90 mmHg at screening or admission to Period 1
- Presence or prior history of abnormal bleeding or bleeding disorders, or any volunteer with significant history of peptic ulcer disease or other acid related gastrointestinal symptoms
- Any gastrointestinal disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Randomised, 3-way Crossover Study to Demonstrate Bioequivalence of a Single Oral Dose of Naproxen Administered as VIMOVO Manufactured at AstraZeneca AB Compared to That of VIMOVO Manufactured by Patheon Pharmaceuticals and a Marketed Enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers
The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen formulation.
Read the detailed description
A Phase I, Open-label, Randomised, 3-way Crossover Study to demonstrate Bioequivalence of a Single Oral Dose of Naproxen administered as VIMOVO manufactured at AstraZeneca AB compared to that of VIMOVO manufactured by Patheon Pharmaceuticals and a marketed enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers.
- Conditions
- Healthy Volunteers, Bioequivalence
- Being tested
- VIMOVO (AstraZeneca), VIMOVO (Patheon), Marketed enteric-coated naproxen formulation
- Keywords
- Phase 1, crossover, bioequivalence, naproxen, esomeprazole, vimovo, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIMOVO (AstraZeneca)Drug
Also called Treatment A
VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
VIMOVO (Patheon)Drug
Also called Treatment B
VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
Marketed enteric-coated naproxen formulationDrug
Also called Treatment C
Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment order : A, B, C Receives: Drug: VIMOVO (AstraZeneca); Drug: VIMOVO (Patheon); Drug: Marketed enteric-coated naproxen formulation |
| 2 | Experimental | Treatment order : B, C, A Receives: Drug: VIMOVO (AstraZeneca); Drug: VIMOVO (Patheon); Drug: Marketed enteric-coated naproxen formulation |
| 3 | Experimental | Treatment order : C, A, B Receives: Drug: VIMOVO (AstraZeneca); Drug: VIMOVO (Patheon); Drug: Marketed enteric-coated naproxen formulation |
| 4 | Experimental | Treatment order : A, C, B Receives: Drug: VIMOVO (AstraZeneca); Drug: VIMOVO (Patheon); Drug: Marketed enteric-coated naproxen formulation |
| 5 | Experimental | Treatment order : B, A, C Receives: Drug: VIMOVO (AstraZeneca); Drug: VIMOVO (Patheon); Drug: Marketed enteric-coated naproxen formulation |
| 6 | Experimental | Treatment order : C, B, A Receives: Drug: VIMOVO (AstraZeneca); Drug: VIMOVO (Patheon); Drug: Marketed enteric-coated naproxen formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in area under the plasma concentration-time curve (AUC) from time zero to infinity
Measured: Pre-dose to Day 4
Secondary outcomes (4)
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Measured: Day 1
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Measured: Day 2
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Measured: Day 3
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stepehn Kanes, Study director, AstraZeneca, Wilmington, USAKingsley Urakpo, MD, Principal investigator, Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331993
- Sponsor's protocol ID
- D1120C00030
- Status last verified
- Oct 2011
- First submitted
- 11 Mar 2011
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Randomised, 3-way Crossover Study to Demonstrate Bioequivalence of a Single Oral Dose of Naproxen Administered as VIMOVO Manufactured at AstraZeneca AB Compared to That of VIMOVO Manufactured by Patheon Pharmaceuticals and a Marketed Enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01331993
- Acronym / sponsor ID
- D1120C00030
- Conditions
- Healthy Volunteers, Bioequivalence
- Keywords
- Phase 1, crossover, bioequivalence, naproxen, esomeprazole, vimovo, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Apr 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 primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen formulation.
Detailed description
A Phase I, Open-label, Randomised, 3-way Crossover Study to demonstrate Bioequivalence of a Single Oral Dose of Naproxen administered as VIMOVO manufactured at AstraZeneca AB compared to that of VIMOVO manufactured by Patheon Pharmaceuticals and a marketed enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: VIMOVO (AstraZeneca), Drug: VIMOVO (Patheon), Drug: Marketed enteric-coated naproxen formulationTreatment order : A, B, C |
| 2 | Experimental | Drug: VIMOVO (AstraZeneca), Drug: VIMOVO (Patheon), Drug: Marketed enteric-coated naproxen formulationTreatment order : B, C, A |
| 3 | Experimental | Drug: VIMOVO (AstraZeneca), Drug: VIMOVO (Patheon), Drug: Marketed enteric-coated naproxen formulationTreatment order : C, A, B |
| 4 | Experimental | Drug: VIMOVO (AstraZeneca), Drug: VIMOVO (Patheon), Drug: Marketed enteric-coated naproxen formulationTreatment order : A, C, B |
| 5 | Experimental | Drug: VIMOVO (AstraZeneca), Drug: VIMOVO (Patheon), Drug: Marketed enteric-coated naproxen formulationTreatment order : B, A, C |
| 6 | Experimental | Drug: VIMOVO (AstraZeneca), Drug: VIMOVO (Patheon), Drug: Marketed enteric-coated naproxen formulationTreatment order : C, B, A |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female volunteer, aged 18 - 55 years (inclusive)
- Female volunteers must be non-pregnant and non-lactating and have a negative urine pregnancy test result prior to enrolment into the study.
- Female volunteers of childbearing potential must be using appropriate birth control during the entire duration of the study
- Body mass index of = 19 to =30 kg/m2 (inclusive) and weights of = 50 to = 100 kg (inclusive)
Key exclusion criteria (4 listed)
- Volunteer who is likely to have unrecognized cardiovascular or cerebrovascular disease, based on history or risk factors, or who has a clinical significant ECG finding at screening
- Uncontrolled hypertension defined as resting systolic pressure >140 mmHg or diastolic pressure >90 mmHg at screening or admission to Period 1
- Presence or prior history of abnormal bleeding or bleeding disorders, or any volunteer with significant history of peptic ulcer disease or other acid related gastrointestinal symptoms
- Any gastrointestinal disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
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 |
|---|---|---|
| VIMOVO (AstraZeneca)Also: Treatment AVIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole | Drug | 1, 2, 3, 4, 5, 6 |
| VIMOVO (Patheon)Also: Treatment BVIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole | Drug | 1, 2, 3, 4, 5, 6 |
| Marketed enteric-coated naproxen formulationAlso: Treatment CMarketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
Change in area under the plasma concentration-time curve (AUC) from time zero to infinity
Time frame: Pre-dose to Day 4
4 secondary outcomes
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Time frame: Day 1
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Time frame: Day 2
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Time frame: Day 3
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Time frame: Day 4
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 Oct 2011.
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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.
Stepehn Kanes study director
AstraZeneca, Wilmington, USA
Kingsley Urakpo, MD principal investigator
Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR, UK
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 VIMOVO (AstraZeneca), VIMOVO (Patheon) and Marketed enteric-coated naproxen formulation in people with Healthy Volunteers and Bioequivalence, run by AstraZeneca at 1 site in United Kingdom.
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 4 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 18 Oct 2011. 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 Kingdom. 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?
Change in area under the plasma concentration-time curve (AUC) from time zero to infinity (time frame: Pre-dose to Day 4). 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 Oct 2011.