DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Perrigo Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bioequivalency

Intervention: Naproxen Tablets, 500 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Perrigo Company

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.

Clinical Details

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

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

Primary outcome: Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: June 2004
Last updated: March 15, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017