Last updated: January 25, 2024
Sponsor: Guangdong Raynovent Biotech Co., Ltd
Overall Status: Completed
Phase
1
Condition
N/ATreatment
Probenecid
ZSP1273
Rosuvastatin
Clinical Study ID
NCT05954624
ZSP1273-23-13
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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);
- Ability to understand and willingness to sign a written informed consent form;
- Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values,or any abnormality that is non-clinically significant.
Exclusion
Exclusion Criteria:
- Participants with a history of hypersensitivity to study drug(ZSP1273,Digoxin,Rosuvastatin,Itraconazole ) or any component of study medication;
- Participants had taken prescription, over-the-counter, herbal, or vitamin productswithin 28 days prior to screening;
- Smoking more than 5 cigarettes per day within 3 months prior to screening,or whocannot stop using any tobacco products during the study period;
- Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior torandomization;
- Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
- 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);
- Participants who test positive at Screening and/or admission (Day -1) for alcoholabuse.
- Females who are pregnant, lactating, or likely to become pregnant during the study.
- 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,
ChinaSite Not Available
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