NCT00860119

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1 healthy

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

March 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

March 10, 2009

Last Update Submit

January 26, 2021

Conditions

Healthy

Keywords

Bioequivalence, Pharmacokinetics, Alprazolam, Sublingual

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)

Sublingual tablet

EXPERIMENTAL

Test treatment

Drug: alprazolam sublingual tablet

Oral tablet

EXPERIMENTAL

Reference treatment

Drug: alprazolam oral tablet

Interventions

alprazolam sublingual tabletDRUG

1 mg alprazolam sublingual tablet, given as a single dose to each subject

Sublingual tablet
alprazolam oral tabletDRUG

1 mg alprazolam immediate release oral tablet, given as a single dose to each subject

Also known as: Xanax
Oral tablet

Eligibility Criteria

Age21 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

Study Sites (1)

Pfizer Investigational Site

Ahmedabad, Gujarat, 380 015, India

Location

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

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

March 10, 2009

First Posted

March 11, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

IN(1)