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Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

Last updated on May 10, 2018

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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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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
Intervention Model: Crossover Assignment
Masking: None (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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00939562
A1901003
No
Not Provided
Not Provided
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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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