Single/Multiple Dose Bioavailability Trial
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00751556
First received: September 11, 2008
Last updated: April 22, 2013
Last verified: April 2013
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Purpose
To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660 mg relative to the established commercial Aleve 220 mg tablet following single dose administration and at steady-state following multiple dose administration for 4 days.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Naproxen Sodium 660mg Drug: Commercial Aleve 220 mg |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Randomized, Two-Way Crossover Trial to Determine the Pharmacokinetic Profile of an Extended Release Naproxen Sodium Tablet Relative to Aleve Tablets Following Single and Multiple Dose Administration in Healthy Adult Subjects |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Pharmacokinetics parameters [ Time Frame: Over 48 Hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess the safety and tolerability of the investigational product [ Time Frame: Over 48 Hours ] [ Designated as safety issue: Yes ]
| Enrollment: | 55 |
| Study Start Date: | February 2008 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Naproxen Sodium 660mg
Extended release Naproxen Sodium (660mg) administered once a day
|
| Active Comparator: Arm 2 |
Drug: Commercial Aleve 220 mg
Immediate release commercial Aleve (220 mg) administered in a 2 (440 mg) plus one (220 mg) dosing schedule, 660 mg total
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy, ambulatory, male and female volunteers between 18 - 55 years of age with BMI of approximately 18 to 30 kg/m2, and total body weight >50 kg (110Ibs)
Exclusion Criteria:
- History of hypersensitive to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
- History of gastrointestinal bleeding or perforation related to previous Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy Active, or history of current peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
- Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Head Clinical Pharmacology, Bayer Consumer Care Inc. |
| ClinicalTrials.gov Identifier: | NCT00751556 History of Changes |
| Other Study ID Numbers: | 13106 |
| Study First Received: | September 11, 2008 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Naproxen Sodium Bioavailability |
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