Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256151
• Other study ID #: A6131024
• Status: Completed
• Phase: Phase 1
• Start date: January 2011
• Est. completion date: May 2011

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders

Intervention

Drug:
• Alprazolam tablet
1 mg single dose of alprazolam conventional tablet
• Alprazolam sublingual
1 mg single dose of alprazolam sublingual tablet

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) from time zero to last measurable time of alprazolam		72 hours
Primary	Peak concentration of alprazolam		72 hours
Secondary	Area under the curve from time zero to infinity		72 hours
Secondary	AUC% extrapolated		72 hours
Secondary	Time of Cmax		72 hours
Secondary	half-life of alprazolam		72 hours
Secondary	Clinically significant safety laboratory tests		Screening, Day 0, Day 4
Secondary	Clincally significant vital signs		Screening, Day 4
Secondary	Clinically significant adverse events		1 month

External Links

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