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Trial record 1 of 1 for:    NCT00939562
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Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00939562
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : December 23, 2009
Last Update Posted : December 23, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE July 8, 2009
First Posted Date  ICMJE July 15, 2009
Results First Submitted Date  ICMJE November 19, 2009
Results First Posted Date  ICMJE December 23, 2009
Last Update Posted Date December 23, 2009
Study Start Date  ICMJE November 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2009)
  • Maximum Plasma Concentration (Cmax) of Doxycycline [ Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose. ]
  • Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline [ Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose. ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2009)
Pharmacokinetics: Cmax (peak plasma conc) and AUC (area under the conc time curve). [ Time Frame: 17-DEC-2008 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2009)
Adverse events [ Time Frame: 17-DEC-2008 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
Official Title  ICMJE An Open-Label, Two-Treatment, Two-Period, Randomized Cross-Over Study To Assess The Bioequivalence Between Commercial Doxycycline Carragenate And Monohydrate Tablet Formulations In Normal Healthy Male Subjects
Brief Summary The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Bacterial Infection
Intervention  ICMJE
  • Drug: doxycycline monohydrate tablet
    Tablet, 100 mg, Single dose
  • Drug: doxycycline carragenate tablet
    Tablet, 100 mg, Single dose
Study Arms  ICMJE
  • Experimental: doxycycline monohydrate tablet
    Intervention: Drug: doxycycline monohydrate tablet
  • Active Comparator: doxycycline carragenate tablet
    Intervention: Drug: doxycycline carragenate tablet
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: July 14, 2009)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects between the ages of 18 and 55 years.
  • Body Mass Index (BMI) of 18 to 30 kg/m2.

Exclusion Criteria:

  • Evidence or history of clinically significant abnormality.
  • Any condition possibly affecting drug absorption.
  • A positive urine drug screen.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00939562
Other Study ID Numbers  ICMJE A1901003
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 November 2009

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