The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Test product(T):100mg CM082 tablet manufactured by Betta Pharmaceuticals
Reference product(R):100mg CM082 tablet manufactured by Catalent Pharma Solutions
The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China
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
Time frame: 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
Time frame: 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
Time frame: 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]
Percentage of adverse events
Percentage of adverse events as assessed by CTCAE v4.03
Time frame: From the first occurrence of adverse events after administration to the cessation of adverse events, assessed up to 2 months
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