Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation
Open-label, Randomized, Single-dose, 2-way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Sublingual Tablet
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2012
Shorter than P25 for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2009
CompletedFirst Posted
Study publicly available on registry
April 8, 2009
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJanuary 28, 2021
January 1, 2021
1 month
April 7, 2009
January 26, 2021
Conditions
Keywords
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 sublingual tablet reference
ACTIVE COMPARATORalprazolam sublingual tablet test
EXPERIMENTALInterventions
0.5 mg sublingual tablet, single dose
Eligibility Criteria
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
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
April 7, 2009
First Posted
April 8, 2009
Study Start
September 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
January 28, 2021
Record last verified: 2021-01