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A Pilot Four-Way Crossover Bioequivalence Trial of Sustained Release Forms of Naproxen Versus Aleve Tablets in Healthy Adult Subjects in a Fasted State
Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.
Details
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 32 |
| Start date | 2007-03 |
| Completion | 2007-05 |
Conditions
- Pain
Interventions
- Naproxen Sodium ER (BAY117031), 20% HPMC
- Naproxen Sodium ER (BAY117031), 30% HPMC
- Naproxen Sodium ER (BAY117031), 40% HPMC
- Aleve (Naproxen Sodium, BAY117031)
Primary outcomes
- Cmax (maximum plasma concentration) for naproxen sodium — Days 0, 1, 2, and 3
- AUC0-24 (partial area under the curve ) for naproxen sodium — Days 0, 1, 2, and 3
- AUC0-t (areas under the curve ) for naproxen sodium — Days 0, 1, 2, and 3
- AUC0-∞ (area under the curve) for naproxen sodium — Days 0, 1, 2, and 3
- Tmax (The first time point where Cmax is reached) for naproxen sodium — Days 0, 1, 2, and 3
- AUC0-8 (partial area under the curve) for naproxen sodium — Days 0, 1, 2, and 3