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

Last updated on December 11, 2019

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Study Location
Pfizer Investigational Site
Col. Arenal Tepepan, Mexico D.F., 14610 Mexico
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pharmacokinetics
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00810316
Pfizer
Completed
Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population

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Descriptive Information
Brief Title  ICMJE Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population
Official Title  ICMJE Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Treatment A
    Intervention: Drug: Alprazolam
  • Treatment B
    Intervention: Drug: Alprazolam XR
  • Treatment C
    Intervention: Drug: Clonazepam
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2008)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00810316
Other Study ID Numbers  ICMJE A6131015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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