Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

NCT ID: NCT01256151

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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Conditions

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Anxiety Disorder

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 conventional tablet

Alprazolam conventional tablet

Group Type ACTIVE_COMPARATOR

Alprazolam tablet

Intervention Type DRUG

1 mg single dose of alprazolam conventional tablet

Alprazolam sublingual tablet

Alprazolam sublingual tablet

Group Type EXPERIMENTAL

Alprazolam sublingual

Intervention Type DRUG

1 mg single dose of alprazolam sublingual tablet

Interventions

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Alprazolam tablet

1 mg single dose of alprazolam conventional tablet

Intervention Type DRUG

Alprazolam sublingual

1 mg single dose of alprazolam sublingual tablet

Intervention Type DRUG

Eligibility Criteria

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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
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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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A6131024

Identifier Type: -

Identifier Source: org_study_id

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