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Open-label, Randomized, Single-dose, 2-way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Sublingual Tablet
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.
Details
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
|---|---|
| Phase | Phase 1 |
| Status | WITHDRAWN |
| Start date | 2012-09 |
| Completion | 2012-10 |
Conditions
- Healthy
Interventions
- alprazolam sublingual tablet commercial
- alprazolam sublingual tablet test
Primary outcomes
- Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax) — 11 days