Bioequivalence
Conditions
Brief summary
The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions. Bioavailability will be evaluated and verified on the basis of pharmacokinetic data.
Interventions
DRUGZSP1273 tablet
Participants receive ZSP1273 tablet orally.
DRUGzsp1273 granules
Participants receive ZSP1273 granules orally.
Sponsors
Guangdong Raynovent Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight \>50 kg 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 an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product. 2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 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 |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Day 1 to Day 20 | The Cmax of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared. |
| Area under the concentration-time curve from time zero to infinity (AUCinf) | Day 1 to Day 20 | The AUCinf of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared. |
| Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast) | Day 1 to Day 20 | The AUClast of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared. |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with drug-related adverse events as assessed by CTCAE v5.0 | Day 1 to Day 20 |
Countries
China
Outcome results
None listed