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Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

NCT ID: NCT00939562

Last Updated: 2009-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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Conditions

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Bacterial Infection

Keywords

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Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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doxycycline monohydrate tablet

Group Type EXPERIMENTAL

doxycycline monohydrate tablet

Intervention Type DRUG

Tablet, 100 mg, Single dose

doxycycline carragenate tablet

Group Type ACTIVE_COMPARATOR

doxycycline carragenate tablet

Intervention Type DRUG

Tablet, 100 mg, Single dose

Interventions

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doxycycline monohydrate tablet

Tablet, 100 mg, Single dose

Intervention Type DRUG

doxycycline carragenate tablet

Tablet, 100 mg, Single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Ahmedabad, Gujarat, India

Site Status

Countries

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India

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1901003&StudyName=Bioequivalence%20Between%20Two%20Tablet%20Formulations%20Of%20Doxycycline%20Carragenate

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Other Identifiers

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A1901003

Identifier Type: -

Identifier Source: org_study_id