A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood
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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.
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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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
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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