Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: alprazolam commercial immediate release oral tablet (Drug); alprazolam test sublingual tablet (Drug)
Phase: Phase 1
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
This study tests the assumption that the bioavailability of alprazolam from a new sublingual
formulation is the same as that from an existing commercial immediate release tablet
Official title: Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)
Alprazolam time of maximum concentration (Tmax) and half life
Adverse events, clinical laboratory tests, vital signs
Minimum age: 18 Years.
Maximum age: 55 Years.
- Healthy male or female subjects
- BMI 17. 5 - 30. 5
- Must provide informed consent
- Clinically significant disease
- Narrow angle glaucoma
- Positive drug screen
Locations and Contacts
To obtain contact information for a study center near you, click here.
Starting date: April 2011
Last updated: May 29, 2012