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An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants

NCT07357610 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-22

No results posted yet for this study

Summary

This study is an open-label, fixed-sequence, two-period Phase 1 clinical trial in healthy adult Chinese participants with a total of 3 cohorts, 16-20 healthy adult Chinese participants are planned to be enrolled in each cohort.

Conditions

  • Healthy Adult Participants

Interventions

DRUG

SIM0270

oral

DRUG

itraconazole

oral

DRUG

Rifampin

oral

DRUG

midazolam

oral

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2026-10-30
Completion
2026-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07357610 on ClinicalTrials.gov