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

NCT07692685 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-28

No results posted yet for this study

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.

Conditions

  • Drug Drug Interaction
  • Pharmacokinetic Profiles
  • Safty

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.

Sponsors & Collaborators

  • Neurodawn Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07692685 on ClinicalTrials.gov