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)”

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.

Study Type: Interventional

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

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• Drug: alprazolam sublingual tablet
  • 1 mg alprazolam sublingual tablet, given as a single dose to each subject
• Drug: alprazolam oral tablet
  • 1 mg alprazolam immediate release oral tablet, given as a single dose to each subject

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Sublingual tablet
  • Test treatment
• Experimental: Oral tablet
  • Reference treatment

Primary Measures

• Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)
  • Time Frame: 11 days
    Safety Issue?: No

Secondary Measures

• Alprazolam time of maximum concentration (Tmax) and half life
  • Time Frame: 11 days
    Safety Issue?: No
• Adverse events, clinical laboratory tests, vital signs
  • Time Frame: 11 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00860119

Study ID Number: A6131017

ClinicalTrials.gov Identifier: NCT00860119

Health Authority: India: Drugs Controller General of India

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