Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions
This study has been completed.
Sponsor:
Perrigo Company
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT00803764
First received: December 5, 2008
Last updated: March 15, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bioequivalency |
Drug: Naproxen Tablets, 500 mg |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Perrigo Company:
Primary Outcome Measures:
- Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | June 2004 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Test Product | Drug: Naproxen Tablets, 500 mg |
| Active Comparator: Reference Product | Drug: Naproxen Tablets, 500 mg |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Perrigo Company |
| ClinicalTrials.gov Identifier: | NCT00803764 History of Changes |
| Other Study ID Numbers: | 40062 |
| Study First Received: | December 5, 2008 |
| Last Updated: | March 15, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Perrigo Company:
|
bioequivalency naproxen |
Additional relevant MeSH terms:
|
Naproxen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013