Back to resultsBioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions
Primary Purpose
Bioequivalency
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Naproxen Tablets, 500 mg
Sponsored by
About this trial
This is an interventional treatment trial for Bioequivalency focused on measuring bioequivalency, naproxen
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test Product
Reference Product
Arm Description
Outcomes
Primary Outcome Measures
Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00803764
Brief Title
Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Perrigo Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bioequivalency
Keywords
bioequivalency, naproxen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Product
Arm Type
Active Comparator
Arm Title
Reference Product
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Naproxen Tablets, 500 mg
Primary Outcome Measure Information:
Title
Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions
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