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NCT00939562 Clinical Trial

Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

Bacterial Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00939562
Other study ID # A1901003
Secondary ID
Status Completed
Phase Phase 4
First received July 8, 2009
Last updated November 19, 2009
Start date November 2008
Est. completion date December 2008

Study information
Verified date November 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority India: University of Gujarat
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• doxycycline monohydrate tablet
Tablet, 100 mg, Single dose
• doxycycline carragenate tablet
Tablet, 100 mg, Single dose

Locations
Country Name City State
India Pfizer Investigational Site Ahmedabad Gujarat

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Plasma Concentration (Cmax) of Doxycycline 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. No
Primary Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline 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. No
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