NCT01256151

Brief Summary

To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2010

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

December 6, 2010

Last Update Submit

January 26, 2021

Conditions

Anxiety Disorder

Keywords

Bioequivalencesublingualalprazolampharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Area under the curve (AUC) from time zero to last measurable time of alprazolam

    72 hours

  • Peak concentration of alprazolam

    72 hours

Secondary Outcomes (7)

  • Area under the curve from time zero to infinity

    72 hours

  • AUC% extrapolated

    72 hours

  • Time of Cmax

    72 hours

  • half-life of alprazolam

    72 hours

  • Clinically significant safety laboratory tests

    Screening, Day 0, Day 4

  • +2 more secondary outcomes

Study Arms (2)

Alprazolam conventional tablet

ACTIVE COMPARATOR

Alprazolam conventional tablet

Drug: Alprazolam tablet

Alprazolam sublingual tablet

EXPERIMENTAL

Alprazolam sublingual tablet

Drug: Alprazolam sublingual

Interventions

Alprazolam tabletDRUG

1 mg single dose of alprazolam conventional tablet

Alprazolam conventional tablet
Alprazolam sublingualDRUG

1 mg single dose of alprazolam sublingual tablet

Alprazolam sublingual tablet

Eligibility Criteria

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

You may qualify if:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
  • Signed informed consent.

You may not qualify if:

  • Evidence or history of clinically significant abnormalities
  • Positive drug screen, excessive alcohol and tobacco use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 8, 2010

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

US(1)