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A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets

NCT06165822 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-12-12

No results posted yet for this study

Summary

This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of Itraconazole Capsules/Rifampicin Capsules on pharmacokinetics of TQB3909 tablets in vivo, and the safety of TQB3909 tablets and combined with Itraconazole Capsules/Rifampicin Capsules after single oral dose.

Conditions

  • Advanced Malignant Neoplasm

Interventions

DRUG

TQB3909 tablets

TQB3909 100mg/tablet.

DRUG

Itraconazole capsule

Itraconazole capsule is a strong inhibitor of CYP3A4.

DRUG

Rifampicin capsule

Rifampicin capsule is a strong inducer of CYP3A4.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-01-31
Completion
2024-03-31

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 NCT06165822 on ClinicalTrials.gov