Bioequivalency Study of CM082 Tablet in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.

Detailed Description
-----------------
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of CM082 tablet in Chinese healthy volunteers will also be evaluated.

Official Title
-----------------
Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of CM082 Tablet in Healthy Chinese Volunteers Under Fasted State and After Meal

Conditions
-----------------
Advanced Malignant Solid Tumors

Intervention / Treatment
-----------------
* Drug: CM082 tablet (test product)
* Drug: CM082 tablet (reference product)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male body weight≥50.0kg or female body weight≥45.0kg; BMI between 19.0-26.0 kg/m2(inclusive) Generally in good health, with no history of chronic disease or sever disease No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation Written informed consent Exclusion Criteria: History of food or drug allergies Clinical significant disease or disorders Received surgery in 3 months before screening, or have plan for surgery during the study Participated in other clinical trials within 3 months before screening Intolerant of venipuncture, history of fainting needle and blood Lactose intolerant Drug abusing in 3 months Donated ≥200 mL of blood within 3 months before screening Pregnant or under lactation period (female subjects) Received any prescription drug, over-the-counter drug, prescription drug and Chinese herbal drug in 2 weeks, with the exception of vitamins and acetaminophen Received any vaccine in 4 weeks Excessively smoking, alcohol or coffin-containing beverage drinking in 3 months Other circumstances that is deemed not appropriate for the study

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-R cohort under fasted state<br>Subjects will be administered with one single dose of CM082 tablet (test product) under fasted state, after a wash period of 5 days, the subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state. | Drug: CM082 tablet (test product)<br>* Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals<br>Drug: CM082 tablet (reference product)<br>* Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions<br>|
| Experimental: R-T cohort under fasted state<br>Subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (test product) under fasted state. | Drug: CM082 tablet (test product)<br>* Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals<br>Drug: CM082 tablet (reference product)<br>* Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions<br>|
| Experimental: T-R cohort after meal<br>Subjects will be administered with one single dose of CM082 tablet (test product) after meal, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (reference product) after meal. | Drug: CM082 tablet (test product)<br>* Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals<br>Drug: CM082 tablet (reference product)<br>* Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions<br>|
| Experimental: R-T cohort after meal<br>Subjects will be administered with one single dose of CM082 tablet (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of CM082 tablet (test product) after meal | Drug: CM082 tablet (test product)<br>* Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals<br>Drug: CM082 tablet (reference product)<br>* Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration(Cmax) of CM082 (test product or reference product) under fasted state or after meal | The Cmax ofCM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour] | 
| Area under the plasma concentration versus time curve(AUC) of CM082 (test product or reference product) under fasted state or after meal | The AUC of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour] | 
| Time of maximum concentration (Tmax) of CM082 (test product or reference product) under fasted state or after meal | The Tmax of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of adverse events | Percentage of adverse events as assessed by CTCAE v4.03 | From the first occurrence of adverse events after administration to the cessation of adverse events, assessed up to 2 months |