Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05954624
Other study ID # ZSP1273-23-13
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 10, 2023
Est. completion date November 30, 2023

Study information

Verified date January 2024
Source Guangdong Raynovent Biotech Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The drug-drug interaction study had been designed to investigate the effect of ZSP1273 on the pharmacokinetics of digoxin, Rosuvastatin and the effect of Itraconazole and Probenecid on the pharmacokinetics of ZSP1273


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date November 30, 2023
Est. primary completion date November 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. 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); 2. Ability to understand and willingness to sign a written informed consent form; 3. Normal physical examination, vital signs, 12-lead ECG, 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,Digoxin, Rosuvastatin,Itraconazole ) or any component of study medication; 2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 28 days prior to 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 Electrocardiogram(ECG) abnormalities, or QTcF > 450ms; 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Digoxin
oral
Rosuvastatin
oral
ZSP1273
oral
Itraconazole
oral
Probenecid
oral

Locations

Country Name City State
China The First Affiliated Hospital of Guangzhou University of Chinese medicine Guangzhou

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic - Cmax Maximum observed plasma concentration 0-168 hours
Primary Pharmacokinetic -Area under the curve(AUC) Area under the curve 0-168 hours
Secondary Number of participants with adverse events The safety and tolerability of ZSP1273 alone and in combination with Itraconazole, rosuvastatin, Probenecid and digoxin will be examined. Day1 to Day30
See also
  Status Clinical Trial Phase
Completed NCT05574374 - Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects Phase 1
Completed NCT04557397 - Fruquintinib CYP3A Inhibitor and Inducer Study Phase 1
Completed NCT06031454 - Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin Phase 1
Completed NCT05137600 - A Drug-Drug Interaction Study Between ATI-2173 and Midazolam or Clarithromycin in Healthy Subjects Phase 1
Recruiting NCT06119958 - Drug-drug Interactions Between DWC202313 and DWC202314 in Healthy Subjects Phase 1
Active, not recruiting NCT05812404 - Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects Phase 1
Completed NCT04606537 - Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects Phase 1
Completed NCT04939467 - Dedicated Drug-Drug Interaction (DDI) Study in Healthy Volunteers Phase 1
Completed NCT04542252 - Drug-Drug Interaction Study of Intravenous Administration of SyB V-1901 and Cyclosporine in Japanese Healthy Subjects Phase 1
Enrolling by invitation NCT06037564 - B-free Multistage Trial Phase 4
Completed NCT05123820 - Pharmacokinetics of Omeprazole and Midazolam When Co-administered With ACT-1014-6470 Phase 1
Recruiting NCT04840862 - Impact of Rifabutin on the Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Phase 4
Completed NCT04814498 - Drug-Drug Interaction (DDI) Study in Healthy Volunteers Phase 1
Completed NCT01350921 - Evaluation of the Drug-drug Interaction Between Ticagrelor and Venlafaxine When Taken Together in Healthy Volunteers Phase 1
Completed NCT03103568 - A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers Phase 1
Completed NCT04840641 - Flucloxacillin as an Inducer of CYP-enzymes Phase 1
Completed NCT05860114 - Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3) Phase 1
Completed NCT05845567 - The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2) Phase 1
Completed NCT05304845 - Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects Phase 1
Completed NCT04776499 - Possible Effects of Propylthiouracil, Riociguat and Perphenazine on Circulation of Healthy Volunteers Phase 1