Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions

Bioequivalency Clinical Trial

Official title:

Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803764
• Other study ID #: 40062
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2008
• Last updated: March 15, 2012
• Start date: June 2004

Study information

• Verified date: March 2012
• Source: Perrigo Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fed conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. primary completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• healthy men or women, non-smoker, 18 years of age or older

• willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

• clinically significant illnesses or surgery within 4 weeks prior to study dosing

• body mass index greater than or equal to 30.0

• recent history of drug or alcohol addiction or abuse

• pregnant or lactating women

• history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin

• history of allergic reactions such as asthma, rhinitis, nasal polyps, urticaria, and hypotension associated with the use of aspirin or other NSAIDs

• history or known presence of gastrointestinal ulceration, bleeding and perforation

• use of tobacco products within 6 months prior to study dosing

• evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant

• receipt of any drugs as part of a research study within 30 days prior to study dosing

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bioequivalency

Intervention

Drug:
• Naproxen Tablets, 500 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Perrigo Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity			No