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Completed

NCT Number: NCT00939562

Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

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

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Key information

Conditions

Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site

Ahmedabad, Gujarat, 380 015, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

doxycycline monohydrate tablet

Drug

Tablet, 100 mg, Single dose

doxycycline carragenate tablet

Drug

Tablet, 100 mg, Single dose

Primary outcomes

  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.

    AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 15, 2009
Registry last updated
Dec 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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