Drug Drug Interaction
Conditions
Brief 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
Interventions
Sponsors
Guangdong Raynovent Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic - Cmax | 0-168 hours | Maximum observed plasma concentration |
| Pharmacokinetic -Area under the curve（AUC） | 0-168 hours | Area under the curve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | Day1 to Day30 | The safety and tolerability of ZSP1273 alone and in combination with Itraconazole, rosuvastatin, Probenecid and digoxin will be examined. |
Countries
China
Outcome results
None listed