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DZD9008 and carbamazepine for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Dizal Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 days after study drug administration
Awards & highlights

Summary

This trial studies how two medications, itraconazole and carbamazepine, affect the processing of another drug, DZD9008, in healthy adults. Itraconazole slows down drug breakdown, while carbamazepine speeds it up. The goal is to understand how these changes impact DZD9008. Carbamazepine is a well-established medication used primarily to treat epilepsy and has been studied extensively for its effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 days after study drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 days after study drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with carbamazepine (Part B)
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with itraconazole (Part A)
Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-t) when dosed alone or coadministered with carbamazepine (Part B)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: DZD9008 and itraconazoleExperimental Treatment1 Intervention
Subjects in arm 1 will receive DZD9008 single dose on Day 1, and the second dose of DZD9008 along with itraconazole after the wash-out period.
Group II: DZD9008 and carbamazepineExperimental Treatment1 Intervention
Subjects in arm 2 will receive DZD9008 single dose on Day 1, and the second dose of DZD9008 along with carbamazepine after the wash-out period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itraconazole
FDA approved
Carbamazepine
FDA approved

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Dizal PharmaceuticalsLead Sponsor
20 Previous Clinical Trials
2,009 Total Patients Enrolled
Tianwei ZhangStudy DirectorDizal Pharma
~11 spots leftby Sep 2025
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