Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Active, not recruiting
Pfizer
2014-01-10
The purpose of this study is to understand safety (e.g., occurrence of adverse drug reactions
[ADRs]) and efficacy data on the long-term use of Vyndaqel Capsules (hereinafter referred to
as Vyndaqel) in all patients who received this drug under actual use conditions after its
marketing.
A Bioequivalence Study Comparing Two Different Tafamidis Formulations
Completed
Pfizer
Phase 1
2014-10-01
Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis
blood concentrations will be measured periodically for one week. After about 20 days,
subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis
concentrations from the two different formulations will be compared to determine if they are
approximately the same.
A Drug-Drug Interaction Study To Estimate The Effect Of Tafamidis On Rosuvastatin Pharmacokinetics
Completed
Pfizer
Phase 1
2020-02-06
Each subject will be given a single oral dose of rosuvastatin on Day 1 in Period 1. In Period
2, after a washout period of at least 5 days, each subject will receive oral doses of
tafamidis twice daily (BID) on days 1 and 2, followed by tafamidis once daily (QD) on days 3
to 9 with an oral dose of rosuvastatin on Day 7. Rosuvastatin exposures will be compared
between Periods 1 and 2 to estimate the effect of tafamidis on rosuvastatin PK in healthy
subjects.
The Effect Of Tafamidis Meglumine In Transthyretin Amyloid Polyneuropathy Patients
Recruiting
Pfizer
Phase 4
2021-04-28
This is a single-arm, open-label, multicenter study designed to determine the effect of
tafamidis meglumine on TTR stabilization as well as tafamidis meglumine safety, tolerability
and efficacy in ATTR-PN patients in China.
Approximately 10-15 participants are planned to be enrolled. All enrolled participants will
receive oral tafamidis meglumine 20 mg soft capsules once daily for 48 weeks.
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