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A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples

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NCT02189330

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brussels, , B-1070 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02189330
Pfizer
Completed
A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples

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Pfizer Clinical Trials Contact Center

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[email protected]

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A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples
A Phase 1, Open-Label, Randomized, 2-Cohort, Crossover, Single Dose Study to Estimate the Relative Bioavailability of PF 06291826 (Tafamidis) Following Administration of Two Oral Formulations Versus Commercial Capsule in Healthy Subjects Under Fasted Conditions
All subjects in this study will be given tafamidis. After swallowing a single pill of tafamidis, measurements including blood samples will be compared to see if tafamidis made in different ways is about the same. After approximately 28 days subjects will be given another pill of tafamidis and the study measurements will be repeated.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Tafamidis
    20 mg of current commercial formulation.
  • Drug: Tafamidis
    12.2 mgA free acid tablet.
  • Drug: Tafamidis
    20 mg new soft gelatin capsule.
  • Drug: Tafamidis
    4 capsules of 20 mg tafamidis of current commercial formulation.
  • Drug: Tafamidis
    4 capsules of 12.2 mg tafamidis of free acid tablet..
  • Experimental: Tafamidis
    Intervention: Drug: Tafamidis
  • Experimental: Tafamudus Free Acid
    Intervention: Drug: Tafamidis
  • Experimental: 20 mg new soft gelatin capsule
    Intervention: Drug: Tafamidis
  • Experimental: 4 capsules of 20 mg tafamidis of commercial formulation
    Intervention: Drug: Tafamidis
  • Experimental: 4 capsules of 12.2 mg tafamidis of free acid tablet
    Intervention: Drug: Tafamidis
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2014
July 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02189330
B3461030
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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