Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

NCT ID: NCT01285505

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-06-30

Brief Summary

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This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Alprazolam commercial sublingual tablet

Group Type ACTIVE_COMPARATOR

alprazolam commercial sublingual formulation

Intervention Type DRUG

0.5 mg tablet, single dose

Alprazolam test sublingual tablet

Group Type EXPERIMENTAL

alprazolam test sublingual tablet

Intervention Type DRUG

0.5 mg tablet, single dose

Interventions

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alprazolam commercial sublingual formulation

0.5 mg tablet, single dose

Intervention Type DRUG

alprazolam test sublingual tablet

0.5 mg tablet, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy male or female subjects
* BMI 18 to 26.9
* must give informed consent

Exclusion Criteria

* clinically significant disease
* narrow angle glaucoma
* positive drug screen
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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A6131020

Identifier Type: -

Identifier Source: org_study_id

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