Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00810316

Purpose

To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release, and clonazepam tablet.

Condition	Intervention	Phase
Pharmacokinetics	Drug: Alprazolam Drug: Alprazolam XR Drug: Clonazepam	Phase I

Drug Information available for: Alprazolam Clonazepam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Parallel Assignment, Pharmacokinetics Study
Official Title:	Pharmacokinetic Comparison Among Two Alprazolam Formulations (Immediate-Release And Modified-Release) And A Clonazepam Formulation In Healthy Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:

AUC last: Area under the curve of plasma concentration from administration up to time t (last sampling timepoint) calculated by trapezoid method. [ Time Frame: Sampling times: 0 to 96 hours ] [ Designated as safety issue: No ]
AUC inf: Area under the curve of plasma concentration from administration up to infinitum extrapolated time. [ Time Frame: Sampling times: 0 to 96 hours ] [ Designated as safety issue: No ]
Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile. [ Time Frame: Sampling times: 0 to 96 hours ] [ Designated as safety issue: No ]
t 1/2: Half life time. [ Time Frame: Sampling times: 0 to 96 hours ] [ Designated as safety issue: No ]
Tmax: Time from administration up to maximum plasma concentration, graphically obtained based on plasma concentration versus time profile. [ Time Frame: Sampling times: 0 to 96 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

No Secondary Outcomes [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	October 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment A	Drug: Alprazolam Administration of a single oral dose tablet of 1 mg of alprazolam immediate release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions
Treatment B	Drug: Alprazolam XR Administration of a single oral dose tablet of 1 mg of alprazolam modified release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions
Treatment C	Drug: Clonazepam Administration of a single oral dose of two tablets of 0.5 mg of clonazepam on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions

Detailed Description:

To determine pharmacokinetics of alprazolam and clonazepam in Latin-American population; in Mexico, both drugs are still widely used as first or second choice in the treatment of anxiety disorders.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or female volunteers aged between 18 and 40 years old.

Exclusion Criteria:

Subjects presenting changes on their vital signs constants registered at volunteers' screening.
Volunteers with any of the following: noncompliance of proposed inclusion criteria; requiring another drug product throughout the study conduction; pregnant or nursing females; history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal, neurological, endocrine, psychiatric, hematopoietic or any other anemia kind, disease, asthma, or organic disorder; history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer or any condition possibly affecting drug absorption; history of acute narrow or glaucoma; exposed to drug products known as hepatic enzyme or inductors; who had received any drug product within 14 days or 5 half lives; who had been hospitalized due to any problem within 60 days prior to study start; history of sensitivity to BZD; who had drink alcohol or any beverage containing xanthines or who had taken smoked food or grapefruit juice within 72 hours prior to start hospitalization period, who had blood donated or lost 450 mL or more within 60 days prior to study start; requiring any special diet regardless the cause.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810316

Locations

Mexico, Mexico D.F.
Pfizer Investigational Site
Col. Arenal Tepepan, Mexico D.F., Mexico, 14610

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6131015
Study First Received:	December 16, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00810316
Health Authority:	Mexico: Ministry of Health

Keywords provided by Pfizer:

Alprazolam
Alprazolam extended release
Clonazepam

Pharmacokinetics
Mexican population
Healthy

Study placed in the following topic categories:

Alprazolam
Clonazepam
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
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009