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Bioequivalence of Alprazolam Sublingual vs Oral Tablets

NCT00860119 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

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 a standard orally administered tablet.

Conditions

  • Healthy

Interventions

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

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
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • India

Study Locations

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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 NCT00860119 on ClinicalTrials.gov