Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

Pfizer24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Bacterial Infection

Interventions

doxycycline monohydrate tabletDRUG

Tablet, 100 mg, Single dose

doxycycline carragenate tabletDRUG

Tablet, 100 mg, Single dose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Ahmedabad, Gujarat, India

Outcomes

Primary Outcomes

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.

Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline

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

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.

Data from ClinicalTrials.gov

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