Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273

Study Overview
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Brief Summary
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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.

Official Title
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Single-dose, Open-label, Randomized, Crossover Bioavailability Study of 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273 Under Fasted Condition in Healthy Participants

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: ZSP1273 tablet
* Drug: zsp1273 granules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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); 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 Criteria: 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. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening； 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; Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization; 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 Syphilis spirochete-specific antibodies (TPPA); Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse. Females who are pregnant, lactating, or likely to become pregnant during the study. History of dysphagia or any gastrointestinal disorder that affect absorption

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZSP1273 Sequence 1<br>Single oral dose of 200mg ZSP1273 tablet administered under fasting conditions in first period and 200mg granules in second period，then 200mg ZSP1273 tablet administered under fasting conditions in third period and 200mg granules in fourth period. | Drug: ZSP1273 tablet<br>* Participants receive ZSP1273 tablet orally.<br>Drug: zsp1273 granules<br>* Participants receive ZSP1273 granules orally.<br>|
| Experimental: ZSP1273 Sequence 2<br>Single oral dose of 200mg ZSP1273 granules administered under fasting conditions in first period and 200mg tablet in second period，then 200mg ZSP1273 granules administered under fasting conditions in third period and 200mg tablet in fourth period. | Drug: ZSP1273 tablet<br>* Participants receive ZSP1273 tablet orally.<br>Drug: zsp1273 granules<br>* Participants receive ZSP1273 granules orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) | The Cmax of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared. | Day 1 to Day 20 | 
| Area under the concentration-time curve from time zero to infinity (AUCinf) | The AUCinf of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared. | Day 1 to Day 20 | 
| Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast) | The AUClast of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared. | Day 1 to Day 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with drug-related adverse events as assessed by CTCAE v5.0 |  | Day 1 to Day 20 |