Drug-durg Interaction of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid

Last updated: January 25, 2024
Sponsor: Guangdong Raynovent Biotech Co., Ltd
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Probenecid

ZSP1273

Rosuvastatin

Clinical Study ID

NCT05954624
ZSP1273-23-13
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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 weightaccording 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

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 productswithin 28 days prior to screening;
  3. Smoking more than 5 cigarettes per day within 3 months prior to screening,or whocannot stop using any tobacco products during the study period;
  4. Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior torandomization;
  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 Syphilisspirochete-specific antibodies (TPPA);
  7. Participants who test positive at Screening and/or admission (Day -1) for alcoholabuse.
  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

Total Participants: 49
Treatment Group(s): 5
Primary Treatment: Probenecid
Phase: 1
Study Start date:
July 10, 2023
Estimated Completion Date:
November 30, 2023

Connect with a study center

  • The First Affiliated Hospital of Guangzhou University of Chinese medicine

    Guangzhou,
    China

    Site Not Available

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