Skip to main content
OpenTrials
Completed

NCT Number: NCT00860119

Bioequivalence of Alprazolam Sublingual vs Oral Tablets

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Ahmedabad, Gujarat, 380 015, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alprazolam sublingual tablet

Drug

1 mg alprazolam sublingual tablet, given as a single dose to each subject

alprazolam oral tablet

Drug

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

Other names: Xanax

Primary outcomes

  1. Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)

    Time frame: 11 days

Secondary outcomes

  1. Alprazolam time of maximum concentration (Tmax) and half life

    Time frame: 11 days

  2. Adverse events, clinical laboratory tests, vital signs

    Time frame: 11 days

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 11, 2009
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.