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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00810316
First received: December 16, 2008
Last updated: September 30, 2009
Last verified: September 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population

Resource links provided by NLM:


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
Other Name: Tafil, Xanax
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
Other Name: Tafil AP, Xanax XR
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
Other Name: Rivotril

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

Locations
Mexico
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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00810316     History of Changes
Other Study ID Numbers: A6131015
Study First Received: December 16, 2008
Last Updated: September 30, 2009
Health Authority: Mexico: Ministry of Health

Keywords provided by Pfizer:
Alprazolam
Alprazolam extended release
Clonazepam
Pharmacokinetics
Mexican population
Healthy

Additional relevant MeSH terms:
Alprazolam
Clonazepam
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
Anticonvulsants

ClinicalTrials.gov processed this record on August 28, 2014