- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01285505
Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation
January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet
This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy male or female subjects
- BMI 18 to 26.9
- must give informed consent
Exclusion Criteria:
- clinically significant disease
- narrow angle glaucoma
- positive drug screen
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Alprazolam commercial sublingual tablet
|
0.5 mg tablet, single dose
|
Experimental: Alprazolam test sublingual tablet
|
0.5 mg tablet, single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC)
Time Frame: 11 days
|
11 days
|
Alprazolam bioavailability as assessed by peak concentration (Cmax)
Time Frame: 11 days
|
11 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Alprazolam time of maximum concentration (Tmax)
Time Frame: 11 days
|
11 days
|
Half life of alprazolam
Time Frame: 11 days
|
11 days
|
Clinically significant safety laboratory tests
Time Frame: 11 days
|
11 days
|
Clinically significant adverse events
Time Frame: 11 days
|
11 days
|
Clinically significant vital signs
Time Frame: 11 days
|
11 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Anticipated)
June 1, 2011
Study Completion (Anticipated)
June 1, 2011
Study Registration Dates
First Submitted
January 26, 2011
First Submitted That Met QC Criteria
January 26, 2011
First Posted (Estimate)
January 28, 2011
Study Record Updates
Last Update Posted (Actual)
January 28, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6131020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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