Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E

Healthy Clinical Trial

Official title:

Phase I, Open-label, Randomized, 2-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Naprosyn E Under Fasting and Fed Conditions in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907400
• Other study ID #: D1120C00024
• Secondary ID: EudraCT No 2009-
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2009
• Last updated: December 8, 2010
• Start date: May 2009
• Est. completion date: September 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PN400
oral tablet
• Naproxen
oral tablet

Locations

Country	Name	City	State
Sweden	Research Site	Lulea
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics		pre-dose and multiple times post-dose	No
Secondary	Safety		Throughout study	Yes