Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00969449
First received: August 31, 2009
Last updated: May 16, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration for 36 hours under fasted conditions
| Condition | Intervention | Phase |
|---|---|---|
|
Pharmacokinetics |
Drug: Naproxen Sodium, (BAY H6689) Drug: Naprelan, (BAY H6689) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Randomized, Two-Way Crossover Trial to Compare the Pharmacokinetic Parameters of an Extended- Release Naproxen Sodium Tablet Relative to Naprelan® Tablets Following Single Dose Administration Under Fasted Conditions |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Pharmacokinetic profile of Naproxen Sodium ER 660 mg compared to Naprelan [ Time Frame: 36 hours ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess safety and tolerability of the extended release naproxen sodium [ Time Frame: 36 hours ] [ Designated as safety issue: Yes ]
- To assess additional pharmacokinetic parameters [ Time Frame: 36 hours ] [ Designated as safety issue: Yes ]
| Enrollment: | 28 |
| Study Start Date: | April 2009 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Naproxen Sodium, (BAY H6689)
One dose of Naproxen sodium extended release 660 mg under fasting conditions
|
| Active Comparator: Arm 2 |
Drug: Naprelan, (BAY H6689)
One dose of Naprelan 500 mg (2 tablets) under fasting conditions
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and female subjects between 18 to 55 years of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs)
- Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor
- Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
- Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol
Exclusion Criteria:
- History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
- Females who are pregnant or lactating
- Loss of blood in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury)
- History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies
- Positive alcohol or drug test at Screening and on Day 0 of each Dosing Period
- Have taken any medications (except acceptable forms of birth control) within 10 days prior to dosing or throughout the trial, unless in the opinion of the Investigator and the Sponsor, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject
- Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Head Clinical Pharmacology, Bayer Consumer Care Inc. |
| ClinicalTrials.gov Identifier: | NCT00969449 History of Changes |
| Other Study ID Numbers: | 14566 |
| Study First Received: | August 31, 2009 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Naproxen Sodium |
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 19, 2013