A Bioequivalence Study Comparing Two Different Tafamidis Formulations

January 6, 2015 updated by: Pfizer

A Phase 1, Open-label, Randomized, Crossover, Single Dose Study To Determine The Bioequivalence Of Pf-06291826 (Tafamidis) 20 Mg Capsule Manufactured By Catalent Versus Capsule Manufactured By Pii In Healthy Subjects Under Fasted Conditions

Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis blood concentrations will be measured periodically for one week. After about 20 days, subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis concentrations from the two different formulations will be compared to determine if they are approximately the same.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males or females of non-child bearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 Kg and total body weight more than 50 Kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. Tafamidis
Drug: Tafamidis
20 mg of current commercial formulation
Other Names:
  • Vyndaqel
Drug: Tafamidis
20 mg of new formulation
Other Names:
  • Vyndaqel
Experimental: 2. Tafamidis
Drug: Tafamidis
20 mg of current commercial formulation
Other Names:
  • Vyndaqel
Drug: Tafamidis
20 mg of new formulation
Other Names:
  • Vyndaqel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 168 hours
168 hours
Area under the Concentration-Time Curve (AUC)
Time Frame: 168 hours
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
168 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 168 hours
168 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time Frame: 168 hours
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
168 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 168 hours
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
168 hours
Plasma Decay Half-Life (t1/2)
Time Frame: 168 hours
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Estimate)

January 7, 2015

Last Update Submitted That Met QC Criteria

January 6, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • B3461044
  • 2014-003271-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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