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A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood

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ClinicalTrials.gov Identifier: NCT03266705
Recruitment Status : Completed
First Posted : August 30, 2017
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
2 different formulations and doses of tafamidis will be compared. All subjects will receive both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects will be fasted before taking the drug. Blood samples will be taken to measure the amount of tafamidis starting on day 7 and ending on day 8. At least 16 days after the first formulation/dose is given, all subjects will repeat the procedure with the other formulation/dose.

Condition or disease Intervention/treatment Phase
Healthy Drug: tafamidis Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-label, Randomized, Crossover, Multiple Dose, Pivotal Bioequivalence Study To Compare Pf-06291826 4 X 20 Mg Tafamidis Meglumine And 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Administered Under Fasted Conditions To Healthy Volunteers
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : March 1, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 61 mgA tafamidis free acid soft gelatin capsule Drug: tafamidis
bioequivalence study
Experimental: 4x20 mg tafamidis meglumine soft gelatin capsule Drug: tafamidis
bioequivalence study


Outcome Measures
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Primary Outcome Measures :
  1. Area under the concentration-time curve (AUC) [ Time Frame: 24 hours ]
  2. maximum observed plasma concentration (Cmax) [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. minimum observed plasma concentration (Cmin) [ Time Frame: 24 hours ]
  2. Time to maximum observed plasma concentration (Tmax) [ Time Frame: 24 hours ]

Eligibility Criteria
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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 of females of non-childbearing potential
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

Exclusion Criteria:

  • Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
  • Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer)
  • Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.
Contacts and Locations
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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): NCT03266705


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
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03266705    
Other Study ID Numbers: B3461056
2017-002572-15 ( EudraCT Number )
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes