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

NCT00803764 | Completed Phase 1

• 1 other identifier: 40062
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bioequivalency

Keywords

bioequivalency; naproxen

Outcome Measures

Primary Outcomes (1)

• Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity

Study Arms (2)

Test Product

ACTIVE COMPARATOR

Drug: Naproxen Tablets, 500 mg

Reference Product

ACTIVE COMPARATOR

Drug: Naproxen Tablets, 500 mg

Interventions

Naproxen Tablets, 500 mg DRUG

Reference Product; Test Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy men or women, non-smoker, 18 years of age or older
• willing to participate and sign a copy of the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Perrigo Company: lead

MeSH Terms

Interventions

Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: June 1, 2004
• Primary Completion: July 1, 2004
• Last Updated: March 16, 2012

Record last verified: 2012-03