Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: alprazolam commercial sublingual formulation; Drug: alprazolam test sublingual tablet

• Registration Number: NCT01285505
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-28
• 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• Status: WITHDRAWN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 18 to 26.9
• must give 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 sublingual tablet	alprazolam commercial sublingual formulation	-
Alprazolam test sublingual tablet	alprazolam test sublingual tablet	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Alprazolam time of maximum concentration (Tmax)	11 days
Half life of alprazolam	11 days
Clinically significant safety laboratory tests	11 days
Clinically significant adverse events	11 days
Clinically significant vital signs	11 days