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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
  Purpose

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


Condition Intervention Phase
Bacterial Infection
 Drug: doxycycline monohydrate tablet
Drug: doxycycline carragenate tablet
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: November 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939562

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00939562     History of Changes
Other Study ID Numbers: A1901003
Study First Received: July 8, 2009
Results First Received: November 19, 2009
Last Updated: November 19, 2009
Health Authority: India: University of Gujarat

Keywords provided by Pfizer:
Bioequivalence

Additional relevant MeSH terms:
Bacterial Infections
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on June 17, 2013