Bioequivalence of Alprazolam Sublingual vs Oral Tablets

Verified by: Pfizer, November 2009
First Received: March 10, 2009 | Last Updated: November 11, 2009 | Phase: Phase 1 | Start Date: August 2009
Overall Status: Completed | Estimated Enrollment: 23
  • …
  • Tell a FriendPrint

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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
  • 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 02, 2012

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

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

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00860119