Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Active, not recruiting
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
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
Not yet recruiting
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
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.