Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation

• ClinicalTrials.gov Identifier: NCT00877955
• Recruitment Status: Withdrawn
• First Posted: April 8, 2009
• Last Update Posted: January 28, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: April 7, 2009
• First Posted Date: April 8, 2009
• Last Update Posted Date: January 28, 2021
• Study Start Date: September 2012
• Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 7, 2009): Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax) [ Time Frame: 11 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 7, 2009)

• Alprazolam time of maximum concentration (Tmax) and half life [ Time Frame: 11 days ]
• Adverse events, clinical laboratory tests, vital signs [ Time Frame: 11 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation
• Official Title: Open-label, Randomized, Single-dose, 2-way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Sublingual Tablet
• Brief Summary: This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• Drug: alprazolam sublingual tablet commercial
  0.5 mg sublingual tablet, single dose
• Drug: alprazolam sublingual tablet test
  0.5 mg tablet, single dose

Study Arms

• Active Comparator: alprazolam sublingual tablet reference
  Intervention: Drug: alprazolam sublingual tablet commercial
• Experimental: alprazolam sublingual tablet test
  Intervention: Drug: alprazolam sublingual tablet test

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: March 11, 2015): 0
• Original Estimated Enrollment (submitted: April 7, 2009): 24
• Estimated Study Completion Date: October 2012
• Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00877955
• Other Study ID Numbers: A6131019
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: January 2021