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Drug-Drug Interaction (DDI) Study for TQB3616

NCT06662773 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-29

No results posted yet for this study

Summary

To evaluate the effect of itraconazole/rifampicin on the pharmacokinetics of TQB3616 capsules.

To assess the safety of a single dose of oral TQB3616 capsules and in combination with itraconazole/rifampicin.

Conditions

  • Healthy

Interventions

DRUG

TQB3616 capsule + itraconazole

C2/4/6 inhibitors + CYP3A metabolic enzyme inhibitors

DRUG

TQB3616 capsule + rifampicin

C2/4/6 inhibitors + Non-specific cytochrome P450 enzyme inducer

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
2024-11-30
Primary Completion
2025-03-31
Completion
2025-07-31

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 NCT06662773 on ClinicalTrials.gov