Trials / Completed
CompletedNCT00692016
Fast & Fed Pharmacokinetic (PK) Study
An Open Label, Randomized, Two-Way Crossover Study to Determine the Bioavailability of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet Under Fasting and Fed Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to provide information on how well an extended release formulation (a medication that is released and absorbed over a longer period of time than a regular release formulation of the medication) of naproxen sodium is absorbed into the bloodstream after eating a high calorie breakfast and also after fasting (not eating for 14 hours).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naproxen sodium | Administered under fasting condition |
| DRUG | Naproxen sodium | Administered under fed condition |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2008-02-01
- Completion
- 2008-03-01
- First posted
- 2008-06-06
- Last updated
- 2013-05-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00692016. Inclusion in this directory is not an endorsement.