Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00877955

Purpose

This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.

Condition	Intervention	Phase
Healthy	Drug: alprazolam sublingual tablet commercial Drug: alprazolam sublingual tablet test	Phase I

Drug Information available for: Alprazolam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Sublingual Tablet

Further study details as provided by Pfizer:

Primary Outcome Measures:

Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax) [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Alprazolam time of maximum concentration (Tmax) and half life [ Time Frame: 11 days ] [ Designated as safety issue: No ]
Adverse events, clinical laboratory tests, vital signs [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	May 2009
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
alprazolam sublingual tablet reference: Active Comparator	Drug: alprazolam sublingual tablet commercial 1 mg sublingual tablet, single dose
alprazolam sublingual tablet test: Experimental	Drug: alprazolam sublingual tablet test 1 mg tablet, single dose

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877955

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6131019
Study First Received:	April 7, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00877955 History of Changes
Health Authority:	India: Drugs Controller General of India

Keywords provided by Pfizer:

bioequivalence, pharmacokinetic, alprazolam, sublingual

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Alprazolam
Hypnotics and Sedatives

Psychotropic Drugs
Central Nervous System Depressants
Anti-Anxiety Agents
Healthy

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants

Pharmacologic Actions
Alprazolam
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009