Bioequivalence of Alprazolam Sublingual vs Oral Tablets - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00860119

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: alprazolam sublingual tablet Drug: alprazolam oral tablet	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official 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)

Resource links provided by NLM:

Drug Information available for: Alprazolam

U.S. FDA Resources

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 ]

Enrollment:	23
Study Start Date:	August 2009
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sublingual tablet Test treatment	Drug: alprazolam sublingual tablet 1 mg alprazolam sublingual tablet, given as a single dose to each subject
Experimental: Oral tablet Reference treatment	Drug: alprazolam oral tablet 1 mg alprazolam immediate release oral tablet, given as a single dose to each subject Other Name: Xanax

Eligibility

Ages Eligible for Study:	21 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: NCT00860119

Locations

India
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 015

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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00860119 History of Changes
Other Study ID Numbers:	A6131017
Study First Received:	March 10, 2009
Last Updated:	November 11, 2009
Health Authority:	India: Drugs Controller General of India

Keywords provided by Pfizer:

Bioequivalence, Pharmacokinetics, Alprazolam, Sublingual

Additional relevant MeSH terms:

Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012