Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: alprazolam commercial immediate release oral tablet; Drug: alprazolam test sublingual tablet

• Registration Number: NCT01027689
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing commercial immediate release tablet formulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-07
• Study First Posted: 2009-12-09
• Study Start: 2011-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy male or female subjects
• BMI 17.5 - 30.5
• Must provide informed consent

Exclusion Criteria

• Clinically significant disease
• Narrow angle glaucoma
• Positive drug screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Alprazolam commercial immediate release oral tablet	alprazolam commercial immediate release oral tablet	-
Alprazolam test sublingual tablet	alprazolam test sublingual tablet	-

Primary Outcome Measures

Name	Time	Method
Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)	11 days

Secondary Outcome Measures

Name	Time	Method
Alprazolam time of maximum concentration (Tmax) and half life	11 days
Adverse events, clinical laboratory tests, vital signs	11 days