A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions

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NCT01046162

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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 volunteers (male or female)

- Age between 18-40 years

- body mass index (Quetelet´s index) between 18-27

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


- Unhealthy subjects


- Volunteers who require any medication over the course of the study


- Volunteers who have received investigational drugs within 60 days prior to the study

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions
Official Title  ICMJE An Open Label,Crossover,Randomized Study Of Two Periods,Two Treatments,Two Sequences, And A Single Dose Of Two Oral Drug Products Of Alprazolam 2mg (Tafil (r), Product Of Pharmacia& Upjohn S.a De C.v Vs Xanax 2mg, Product Of Pfizer Pharmaceuticals Llc) In Healthy Volunteers In Fasting Conditions
Brief Summary The purpose of this study is to compare bioavailability between formulations of alprazolam in tablets to determine their bioequivalence in terms of rate and magnitude of absorption.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Alprazolam
    Single tablet
    Other Name: Tafil Pharmacia Upjohn
  • Drug: Alprazolam
    Single tablet
    Other Name: Xanax Pfizer
Study Arms  ICMJE
  • Active Comparator: Tafil Tablets 2 mg Pharmacia Upjohn
    Intervention: Drug: Alprazolam
  • Active Comparator: Xanax Tablets 2 mg Pfizer LLC
    Intervention: Drug: Alprazolam
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 3, 2018)		0
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2010)		26
Estimated Study Completion Date  ICMJE July 22, 2010
Estimated Primary Completion Date July 22, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers (male or female)
  • Age between 18-40 years
  • body mass index (Quetelet´s index) between 18-27

Exclusion Criteria:

  • Unhealthy subjects
  • Volunteers who require any medication over the course of the study
  • Volunteers who have received investigational drugs within 60 days prior to the study
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01046162
Other Study ID Numbers  ICMJE A6131021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP