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Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00939562
First received: July 8, 2009
Last updated: November 19, 2009
Last verified: November 2009
History of Changes

July 8, 2009
November 19, 2009
November 2008
December 2008   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Pharmacokinetics: Cmax (peak plasma conc) and AUC (area under the conc time curve). [ Time Frame: 17-DEC-2008 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00939562 on ClinicalTrials.gov Archive Site
Not Provided
Adverse events [ Time Frame: 17-DEC-2008 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
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

The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Bacterial Infection
  • Drug: doxycycline monohydrate tablet
    Tablet, 100 mg, Single dose
  • Drug: doxycycline carragenate tablet
    Tablet, 100 mg, Single dose
  • Experimental: doxycycline monohydrate tablet
    Intervention: Drug: doxycycline monohydrate tablet
  • Active Comparator: doxycycline carragenate tablet
    Intervention: Drug: doxycycline carragenate tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00939562
A1901003
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2009

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