drugset / Trial / NCT04253353
A Drug-Drug Interaction Study To Estimate The Effect Of Tafamidis On Rosuvastatin Pharmacokinetics
NaSequentialOpen-labelBasic science
Summary
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.
Timeline
- Start
- 2020-02-06
- Primary completion
- 2020-08-10
- Completion
- 2020-08-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rosuvastatin | Small molecule | 10 mg | Oral |
| Subject | Tafamidis | Unknown | 61 mg | Oral |
Indications
No indication recorded.