Healthy
Conditions
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.
Interventions
DRUGtafamidis
bioequivalence study
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve (AUC) | 24 hours |
| maximum observed plasma concentration (Cmax) | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| minimum observed plasma concentration (Cmin) | 24 hours |
| Time to maximum observed plasma concentration (Tmax) | 24 hours |
Countries
Belgium
Outcome results
None listed