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OpenTrials
Completed

NCT Number: NCT01256151

Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

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

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Key information

Conditions

Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

alprazolam tablet

Drug

1 mg single dose of alprazolam conventional tablet

Alprazolam sublingual

Drug

1 mg single dose of alprazolam sublingual tablet

Primary outcomes

  1. Area under the curve (AUC) from time zero to last measurable time of alprazolam

    Time frame: 72 hours

  2. Peak concentration of alprazolam

    Time frame: 72 hours

Secondary outcomes

  1. Area under the curve from time zero to infinity

    Time frame: 72 hours

  2. AUC% extrapolated

    Time frame: 72 hours

  3. Time of Cmax

    Time frame: 72 hours

  4. half-life of alprazolam

    Time frame: 72 hours

  5. Clinically significant safety laboratory tests

    Time frame: Screening, Day 0, Day 4

  6. Clincally significant vital signs

    Time frame: Screening, Day 4

  7. Clinically significant adverse events

    Time frame: 1 month

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 Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 8, 2010
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.

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