A Bioequivalence Study Comparing Two Different Tafamidis Formulations
NCT ID: NCT02217813
Last Updated: 2015-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2014-10-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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1. Tafamidis
Tafamidis
20 mg of current commercial formulation
2. Tafamidis
Tafamidis
20 mg of new formulation
Interventions
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Tafamidis
20 mg of current commercial formulation
Tafamidis
20 mg of new formulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 17.5 to 30.5 Kg and total body weight more than 50 Kg (110 lbs).
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Clinical Research Unit
Brussels, , Belgium
Countries
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Related Links
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Other Identifiers
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2014-003271-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B3461044
Identifier Type: -
Identifier Source: org_study_id
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