An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites
NCT ID: NCT01330472
Last Updated: 2021-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2011-05-31
2011-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
NCT00878514
Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation
NCT01027689
A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets
NCT01322867
Bioequivalence of Alprazolam Sublingual vs Oral Tablets
NCT00860119
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets
NCT00878865
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Xanax XR tablets 3 mg (sourced from Caugus)
Xanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE)
Xanax XR tablets 3 mg (sourced from Caugus)
Tablets, 3 mg, single dose
Xanax XR tablets 3 mg (sourced from Barceloneta),
Xanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST)
Xanax XR tablets 3 mg (sourced from Barceloneta)
Tablets, 3 mg, single dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Xanax XR tablets 3 mg (sourced from Caugus)
Tablets, 3 mg, single dose
Xanax XR tablets 3 mg (sourced from Barceloneta)
Tablets, 3 mg, single dose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* An informed consent document signed and dated by the subject.
Exclusion Criteria
* A positive urine drug screen.
* Subjects who are hypersensitive to alprazolam or related compounds.
20 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A6131025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.