Please note that IPD sharing statement and summary results sections will be added to the ANZCTR form in the coming months in order to comply with the updated WHO Trial Registration Data Set.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00992381




Trial ID
NCT00992381
Ethics application status
Date submitted
8/10/2009
Date registered
8/10/2009
Date last updated
15/01/2010

Titles & IDs
Public title
Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone
Scientific title
A Single Centre, Two Treatment, Two Period, Two Sequence, Randomized Crossover Steady-state Relative Bioavailability Study of Naproxen in Two Tablet Formulations Given Twice Daily (PN 400 Tablets Containing 500 mg of Naproxen Plus 20 mg of Esomeprazole Versus Naprosyn® Containing Naproxen 500 mg)
Secondary ID [1] 0 0
D1120C00035
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PN400
Treatment: Drugs - Naprosyn

Experimental: 1 - PN400

Active Comparator: 2 - Naproxen


Treatment: Drugs: PN400
500mg Naproxen and 20mg esomeprazole

Treatment: Drugs: Naprosyn
500mg Naproxen

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the relative naproxen bioavailability of PN 400 (naproxen 500 mg plus esomeprazole 20 mg) compared to an immediate release Naprosyn® 500 mg tablet
Timepoint [1] 0 0
blood samples taken at various time points over 2 treatment periods of 11 days
Secondary outcome [1] 0 0
To evaluate the pharmacokinetic (PK) properties of the naproxen component of PN 400 tablet and immediate release Naprosyn® 500 mg tablet,
Timepoint [1] 0 0
Blood samples taken at various time point over 2 periods of 2 days
Secondary outcome [2] 0 0
Compare the adverse event profile of PN 400 with that from Naprosyn®
Timepoint [2] 0 0
Adverse event reporting over 2 periods of 11 days

Eligibility
Key inclusion criteria
- Subjects must have a body weight greater than 50 kg and BMI within the range
18-30(inclusive).

- Subjects must be in good health, as assessed during pre-study medical examination and
by review of screening results

- Subjects must understand the procedures involved and agree to participate in the study
by giving fully informed, written consent
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Significant intercurrent disease of any type, in particular liver, kidney,
cardiovascular disease, any form of diabetes or significant gastrointestinal disorder
which could affect drug absorption, or any history of gastric or duodenal ulceration.

- Ingestion of any naproxen, omeprazole, esomeprazole or related drugs prior to the
recruitment interview, such that these drugs will have been ingested in the 4 weeks
prior to the day set for the first Period 1 dose

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Research Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
POZEN
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether the absorption of naproxen from the PN 400
combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets
(Naprosyn®), which are currently sold in Australia.
Trial website
https://clinicaltrials.gov/show/NCT00992381
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Terry Hurst
Address 0 0
Q-Pharm Phase one unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries