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Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

Primary Purpose

Anxiety Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alprazolam tablet
Alprazolam sublingual
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety Disorder focused on measuring Bioequivalence, sublingual, alprazolam, pharmacokinetics

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
  • Signed informed consent.

Exclusion Criteria:

  • Evidence or history of clinically significant abnormalities
  • Positive drug screen, excessive alcohol and tobacco use

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Alprazolam conventional tablet

Alprazolam sublingual tablet

Arm Description

Alprazolam conventional tablet

Alprazolam sublingual tablet

Outcomes

Primary Outcome Measures

Area under the curve (AUC) from time zero to last measurable time of alprazolam
Peak concentration of alprazolam

Secondary Outcome Measures

Area under the curve from time zero to infinity
AUC% extrapolated
Time of Cmax
half-life of alprazolam
Clinically significant safety laboratory tests
Clincally significant vital signs
Clinically significant adverse events

Full Information

First Posted
December 6, 2010
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01256151
Brief Title
Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder
Keywords
Bioequivalence, sublingual, alprazolam, pharmacokinetics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alprazolam conventional tablet
Arm Type
Active Comparator
Arm Description
Alprazolam conventional tablet
Arm Title
Alprazolam sublingual tablet
Arm Type
Experimental
Arm Description
Alprazolam sublingual tablet
Intervention Type
Drug
Intervention Name(s)
Alprazolam tablet
Intervention Description
1 mg single dose of alprazolam conventional tablet
Intervention Type
Drug
Intervention Name(s)
Alprazolam sublingual
Intervention Description
1 mg single dose of alprazolam sublingual tablet
Primary Outcome Measure Information:
Title
Area under the curve (AUC) from time zero to last measurable time of alprazolam
Time Frame
72 hours
Title
Peak concentration of alprazolam
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Area under the curve from time zero to infinity
Time Frame
72 hours
Title
AUC% extrapolated
Time Frame
72 hours
Title
Time of Cmax
Time Frame
72 hours
Title
half-life of alprazolam
Time Frame
72 hours
Title
Clinically significant safety laboratory tests
Time Frame
Screening, Day 0, Day 4
Title
Clincally significant vital signs
Time Frame
Screening, Day 4
Title
Clinically significant adverse events
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. Signed informed consent. Exclusion Criteria: Evidence or history of clinically significant abnormalities Positive drug screen, excessive alcohol and tobacco use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6131024&StudyName=Pharmacokinetics%20Of%20Alprazolam%20Sublingual%20Tablet%20Versus%20Conventional%20Tablet
Description
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Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

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