Drug Drug Interaction Clinical Trial
Official title:
A Open-Label, Two-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid in Healthy Participants
Verified date | January 2024 |
Source | Guangdong Raynovent Biotech Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Guangzhou University of Chinese medicine | Guangzhou |
Lead Sponsor | Collaborator |
---|---|
Guangdong Raynovent Biotech Co., Ltd |
China,
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 |
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