A Bioequivalence Study of Hetrombopag in Healthy Subjects

Study Overview
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Brief Summary
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This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.

Official Title
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Bioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy Subjects

Conditions
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Sever Aplastic Anaemia

Intervention / Treatment
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* Drug: Hetrombopag Olamine Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions; Ability to complete the study as required by the protocol; Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent; Body mass index (BMI) within the range of 19   26 kg /m2 (including 19 and 26); Exclusion Criteria: Allergic constitution; History of drug use, or drug abuse screening positive; Alcoholic or often drinkers; History of deep vein thrombosis, or any other thromboembolic event; A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A: T - R- R<br> | Drug: Hetrombopag Olamine Tablet<br>* Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)<br>|
| Experimental: Treatment group B: R -T - R<br> | Drug: Hetrombopag Olamine Tablet<br>* Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)<br>|
| Experimental: Treatment group C: R- R-T<br> | Drug: Hetrombopag Olamine Tablet<br>* Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) |  | 0-120 hours post dose | 
| Area Under the plasma concentration vs time curve (AUC0-120) |  | 0-120 hours post dose | 
| area under the plasma concentration vs time curve (AUC0-inf) |  | 0-infinity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax) |  | 0-120 hours post dose | 
| Half-life Associated With the Terminal Slope (t½) |  | 0-120 hours post dose | 
| The number of volunteers with adverse events as a measure of safety and tolerability |  | up to Day 26 |