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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

Brief Summary:
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.

Condition or disease Intervention/treatment Phase
Bacterial Infection Drug: doxycycline monohydrate tablet Drug: doxycycline carragenate tablet Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : November 2008
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: doxycycline monohydrate tablet Drug: doxycycline monohydrate tablet
Tablet, 100 mg, Single dose
Active Comparator: doxycycline carragenate tablet Drug: doxycycline carragenate tablet
Tablet, 100 mg, Single dose



Primary Outcome Measures :
  1. 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. ]
  2. 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. ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939562


Locations
India
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 015
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00939562     History of Changes
Other Study ID Numbers: A1901003
First Posted: July 15, 2009    Key Record Dates
Results First Posted: December 23, 2009
Last Update Posted: December 23, 2009
Last Verified: November 2009

Keywords provided by Pfizer:
Bioequivalence

Additional relevant MeSH terms:
Bacterial Infections
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents