drugset
drugset / Trial / NCT03662191

Phase I Safety, Pharmacokinetics and Bioavailability Study Comparing Rate and Extent of Absorption of Two Different Forms of Tafamidis (PF-6291826)

NCT03662191 ↗

Phase 1 Completed 9 enrolled Pfizer
RandomizedCrossoverOpen-labelBasic science

Summary

2 different formulations and 4 different single doses of tafamidis will be compared. All subjects will receive both formulations and 3 different doses. Subjects will be fasted before taking the drug. After swallowing single dose of tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After another 16 days, all subjects will repeat the procedure twice, each time with the other formulation/dose.

Timeline

Start
2018-09-28
Primary completion
2019-01-10
Completion
2019-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tafamidis Unknown 10 mg Oral
Subject Tafamidis Unknown 80 mg Oral
Subject Tafamidis Unknown 100 mg Oral

Indications

No indication recorded.