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Trial record 1 of 1 for:    NCT02697864
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A Study Comparing Amounts of Tafamidis In The Blood Without Food

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ClinicalTrials.gov Identifier: NCT02697864
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open‑Label, Three Period Randomized, Single Dose Study To Estimate The Relative Bioavailability Of Pf‑06291826 (Tafamidis) Free Acid Tablet Formulation Versus Commercial Capsule In Healthy Subjects Under Fasted Conditions
Actual Study Start Date : April 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 48.8 mgA tafamidis free acid tablet Drug: tafamidis
Experimental: 58 mgA tafamidis free acid tablet Drug: tafamidis
Experimental: 4 soft gel capsules of 20 mg tafamidis meglumine Drug: tafamidis



Primary Outcome Measures :
  1. Area under the concentration-time Curve (AUC) [ Time Frame: 120 hours ]
  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 120 hours ]

Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 120 hours ]
  2. Mean residence time (MRT) [ Time Frame: 120 hours ]
  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 120 hours ]
  4. Plasma Decay Half-Life (t1/2) [ Time Frame: 120 hours ]


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 and total body weight more than 50 kg (110 lbs).

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.
  • 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.

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): NCT02697864


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: NCT02697864    
Other Study ID Numbers: B3461051
2016-000295-16 ( EudraCT Number )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017