Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation

Condition(s) targeted: Healthy

Intervention: alprazolam commercial immediate release oral tablet (Drug); alprazolam test sublingual tablet (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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 formulation.

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)

Secondary outcome:

Alprazolam time of maximum concentration (Tmax) and half life

Adverse events, clinical laboratory tests, vital signs

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male or female subjects

- BMI 17. 5 - 30. 5

- Must provide informed consent

Exclusion Criteria:

- Clinically significant disease

- Narrow angle glaucoma

- Positive drug screen

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

Starting date: January 2011
Last updated: August 17, 2010