Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone

Healthy Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992381
• Other study ID #: D1120C00035
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2009
• Last updated: January 15, 2010
• Start date: September 2009
• Est. completion date: October 2009

Study information

• Verified date: January 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PN400
500mg Naproxen and 20mg esomeprazole
• Naprosyn
500mg Naproxen

Locations

Country	Name	City	State
Australia	Research Site	Brisbane	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	POZEN

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		blood samples taken at various time points over 2 treatment periods of 11 days	No
Secondary	To evaluate the pharmacokinetic (PK) properties of the naproxen component of PN 400 tablet and immediate release Naprosyn® 500 mg tablet,		Blood samples taken at various time point over 2 periods of 2 days	No
Secondary	Compare the adverse event profile of PN 400 with that from Naprosyn®		Adverse event reporting over 2 periods of 11 days	Yes