Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

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

To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.

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 alprazolam

Peak concentration of alprazolam

Secondary outcome:

Area under the curve from time zero to infinity

AUC% extrapolated

Time of Cmax

half-life of alprazolam

Clinically significant safety laboratory tests

Clincally significant vital signs

Clinically significant adverse events

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

Pfizer Investigational Site, New Haven, Connecticut 06511, United States

To obtain contact information for a study center near you, click here.

Starting date: January 2011
Last updated: May 24, 2011