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Trial record 3 of 29 for:    tafamidis

A Bioequivalence Study Comparing Two Different Tafamidis Formulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02217813
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Tafamidis Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1. Tafamidis Drug: Tafamidis
20 mg of current commercial formulation
Other Name: Vyndaqel

Experimental: 2. Tafamidis Drug: Tafamidis
20 mg of new formulation
Other Name: Vyndaqel




Primary Outcome Measures :
  1. 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.

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 168 hours ]

Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 168 hours ]
  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217813


Locations
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Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02217813    
Other Study ID Numbers: B3461044
2014-003271-35 ( EudraCT Number )
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015