drugset / Trial / NCT07692685

Pharmacokinetic Effect of Y-3 for Injection on Rosuvastatin Calcium Tablets in Healthy Participants

NCT07692685

Phase 1 Completed 20 enrolled Neurodawn Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelOther

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.

Timeline

Start
2026-05-07
Primary completion
2026-06-04
Completion
2026-06-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Rosuvastatin Small molecule 10 mg Oral
Subject Y-3 Unknown 40 mg Intravenous

Indications

No indication recorded.