Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety Disorder
Intervention: Alprazolam tablet (Drug); Alprazolam sublingual (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To assess if the sublingual tablet will have similar pharmacokinetics as the conventional
tablet of alprazolam.
Clinical Details
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: Area under the curve (AUC) from time zero to last measurable time of alprazolamPeak concentration of alprazolam
Secondary outcome: Area under the curve from time zero to infinityAUC% extrapolated Time of Cmax half-life of alprazolam Clinically significant safety laboratory tests Clincally significant vital signs Clinically significant adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17. 5 to 30. 5 kg/m2.
- Signed informed consent.
Exclusion Criteria:
- Evidence or history of clinically significant abnormalities
- Positive drug screen, excessive alcohol and tobacco use
Locations and Contacts
Pfizer Investigational Site, New Haven, Connecticut 06511, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2011
Last updated: May 24, 2011
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