A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet and Viread® tablet in Chronic hepatitis B Patients Subjects will receive either a single oral dose of the test formulation(CKD-390) or a oral dose of the reference formulation(viread).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
158
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
Time frame: 24weeks after drug administration
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
Time frame: 12, 36, 48 weeks after drug administration
The Difference between the baseline and at the 12, 24, 36, 48 week of HBV DNA level
Time frame: 12, 24, 36, 48 weeks after drug administration
The rate of subjects who had normal ALT result
Time frame: 12, 24, 36, 48weeks after drug administration
The rate of subjects who showed HBeAg loss
Time frame: 24, 48 weeks after drug administration
The rate of subjects who showed HBeAg seroconversion
Time frame: 24, 48 weeks after drug administration
The rate of subjects who showed HBsAg loss
Time frame: 24, 48 weeks after drug administration
The rate of subjects who showed HBsAg seroconversion
Time frame: 24, 48 weeks after drug administration
The rate of subjects who showed Virologic breakthrough
Time frame: 12, 24, 36, 48 weeks after drug administration
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