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Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

Last updated on November 9, 2019

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Study Location
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 015 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infection
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male subjects between the ages of 18 and 55 years.

- Body Mass Index (BMI) of 18 to 30 kg/m2.

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

- Evidence or history of clinically significant abnormality.

- Any condition possibly affecting drug absorption.

- A positive urine drug screen.

NCT00939562
Pfizer
Completed
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

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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 SummaryThe purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
Detailed DescriptionNot 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 DateDecember 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 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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