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NCT01285505 Clinical Trial

Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

Healthy Clinical Trial

Official title:
Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01285505
Other study ID # A6131020
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date April 2011
Est. completion date June 2011

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• alprazolam commercial sublingual formulation
0.5 mg tablet, single dose
• alprazolam test sublingual tablet
0.5 mg tablet, single dose

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC) 11 days
Primary Alprazolam bioavailability as assessed by peak concentration (Cmax) 11 days
Secondary Alprazolam time of maximum concentration (Tmax) 11 days
Secondary Half life of alprazolam 11 days
Secondary Clinically significant safety laboratory tests 11 days
Secondary Clinically significant adverse events 11 days
Secondary Clinically significant vital signs 11 days
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