NCT00860119

Bioequivalence of Alprazolam Sublingual vs Oral Tablets

Open-Label, Randomized, Single-Dose, 2-Way Crossover Pivotal Bioequivalence Study Comparing Alprazolam Immediate Release (IR) Tablets (Administered Orally) And Alprazolam Sublingual (SL) Tablets (Administered Sublingually)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	alprazolam sublingual tablet	1 mg alprazolam sublingual tablet, given as a single dose to each subject
DRUG	alprazolam oral tablet	1 mg alprazolam immediate release oral tablet, given as a single dose to each subject

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-03-11
• Last updated: 2021-01-28

Locations

1 site across 1 country: India