NCT01027689

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_1 healthy

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

December 7, 2009

Last Update Submit

January 26, 2021

Conditions

Healthy

Keywords

alprazolambioequivalencesublingual

Outcome Measures

Primary Outcomes (1)

  • Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)

    11 days

Secondary Outcomes (2)

  • Alprazolam time of maximum concentration (Tmax) and half life

    11 days

  • Adverse events, clinical laboratory tests, vital signs

    11 days

Study Arms (2)

Alprazolam commercial immediate release oral tablet

ACTIVE COMPARATOR
Drug: alprazolam commercial immediate release oral tablet

Alprazolam test sublingual tablet

EXPERIMENTAL
Drug: alprazolam test sublingual tablet

Interventions

alprazolam commercial immediate release oral tabletDRUG

1 mg tablet, single dose

Also known as: Xanax
Alprazolam commercial immediate release oral tablet
alprazolam test sublingual tabletDRUG

1 mg tablet, single dose

Alprazolam test sublingual tablet

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Alprazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

April 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 28, 2021

Record last verified: 2021-01