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
  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:


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:
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 April 17, 2014