Pharmacokinetic Effect of Y-3 for Injection on Rosuvastatin Calcium Tablets in Healthy Participants
brief summary
The primary objective of this study is to evaluate the effect of Y-3 for injection on the pharmacokinetics of rosuvastatin calcium tablets (a sensitive BCRP probe substrate) in healthy participants, in order to assess the potential clinical drug-drug interaction. The results will inform the drafting of the Y-3 for injection package insert and support its safe and rational post-marketing use. The secondary objectives is to evaluate the effect of Y-3 for injection on the safety of rosuvastatin calcium tablets, and to evaluate the effect of rosuvastatin calcium tablets on the pharmacokinetics of Y-3 for injection in healthy participants.
detailed description
This study is a single-center, open-label, single-arm, fixed-sequence, self-controlled study. A total of at least 20 participants (about half men and half women) will be will be enrolled and needed to complete in the study.On Days 1 and 11 of the trial, subjects shall orally take one tablet (10 mg) of rosuvastatin calcium on an fasted in the morning.From Day 5 to Day 14, 40 mg of Y-3 for Injection shall be administered via intravenous infusion once daily in the morning for 10 consecutive days (with an infusion duration of approximately 60 minutes). On Day 11, Y-3 for Injection (40mg) and one tablet (10mg) of rosuvastatin calcium shall be co-administered simultaneously.(with an interval of no more than 1 minute between the two administrations).
official title
A Single-center, Open-label, Single-arm, Fixed-sequence, Self-controlled Study to Evaluate the Pharmacokinetic Effect of Y-3 for Injection on Rosuvastatin Calcium Tablets in Healthy Participants