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

NCT01027689 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-01-28

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

alprazolam commercial immediate release oral tablet

1 mg tablet, single dose

DRUG

alprazolam test sublingual tablet

1 mg tablet, single dose

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-06-30
Completion
2011-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01027689 on ClinicalTrials.gov