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A Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam

A Phase 1, Open-Label, Two-Period，Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam

NCT05942365•Guangdong Raynovent Biotech Co., Ltd

View on ClinicalTrials.gov

Summary

This study is a single-center, open label phase I clinical study to characterize the DDIs potential of ZSP1273 With Warfarin and Midazolam in Chinese healthy participants. This study also aims to evaluate the safety and tolerability of ZSP1273 in the presence of Warfarin and Midazolam.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Adult, male and female participants, 18 to 55 years of age, inclusive, at first Check-In Visit;
•2. Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight \>50 kg(male) or \>45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
•3. Ability to understand and willingness to sign a written informed consent form;
•4. Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion Criteria

•1. Participants with a history of hypersensitivity to study drug(ZSP1273,warfarin, midazolam) or any component of study medication;
•2. Participants with a history of and/or signs and symptoms of current abnormal hemostasis or blood dyscrasia or abnormal prothrombin time (PT), international normalized ratio (INR), or activated partial thromboplastin time at screening;
•3. Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
•4. Participants who donated blood/bleeding profusely (\> 400 mL) 3 months prior to randomization;
•5. Those with clinically significant ECG abnormalities, or QTcF \> 450ms in men and QTcF \> 470ms in women;
•6. Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
•7. Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
•8. Females who are pregnant, lactating, or likely to become pregnant during the study.
•9. History of dysphagia or any gastrointestinal disorder that affect absorption

Locations (1)

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Key Dates

Start Date

June 25, 2023

Primary Completion Date

July 21, 2023

Completion Date

August 4, 2023

Last Updated

December 6, 2023

Enrollment

ACTUAL participants

Conditions

Drug Drug InteractionWarfarinMidazolam

Interventions

ZSP1273

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam

Inclusion Criteria

Exclusion Criteria

EFFECT OF DEXMEDETOMİDİNE ON RECURRENT LARYNGEAL NERVE MONİTORİNG: A COMPARATİVE STUDY WİTH MİDAZOLAM

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