Bioequivalence of Alprazolam Sublingual vs Oral Tablets

Condition(s) targeted: Healthy

Intervention: alprazolam sublingual tablet (Drug); alprazolam oral tablet (Drug)

Phase: Phase 1

Status: 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 a standard orally administered tablet.

Official title: Open-Label, Randomized, Single-Dose, 2-Way Crossover Pivotal Bioequivalence Study Comparing Alprazolam Immediate Release (IR) Tablets (Administered Orally) And Alprazolam Sublingual (SL) Tablets (Administered Sublingually)

Study design: Basic Science, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

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: 21 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

Pfizer Investigational Site, Ahmedabad, Gujarat 380 015, India; Recruiting

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

Starting date: August 2009
Ending date: September 2009
Last updated: September 15, 2009