Open-label, Randomized, Single-Dose, 2 Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet

NCT01256151 Phase 1 COMPLETED

To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.

Details

Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	28
Start date	2011-01
Completion	2011-05

Conditions

• Anxiety Disorder

Interventions

• Alprazolam tablet
• Alprazolam sublingual

Primary outcomes

• Area under the curve (AUC) from time zero to last measurable time of alprazolam — 72 hours
• Peak concentration of alprazolam — 72 hours

Countries

United States