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COMPLETED
NCT07692685
PHASE1

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

Sponsor: Neurodawn Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-05-07

Completion Date

2026-06-04

Last Updated

2026-07-09

Healthy Volunteers

Yes

Interventions

DRUG

Use of rosuvastatin calcium tablet alone or combined with Y-3 for injection

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 . On Day 11, Y-3 for Injection (40mg) and one tablet (10mg) of rosuvastatin calcium shall be co-administered simultaneously.

Locations (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China