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Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

Pfizer logo

Pfizer

Status and phase

Completed
Phase 4

Conditions

Bacterial Infection

Treatments

Drug: doxycycline monohydrate tablet
Drug: doxycycline carragenate tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT00939562
A1901003

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 2 patient groups

doxycycline monohydrate tablet
Experimental group
Treatment:
Drug: doxycycline monohydrate tablet
doxycycline carragenate tablet
Active Comparator group
Treatment:
Drug: doxycycline carragenate tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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