Clinical Trials Directory

Trials / Unknown

UnknownNCT02805738

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

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
158 (estimated)
Sponsor
Chong Kun Dang Pharmaceutical · Industry
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet

Detailed description

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).

Conditions

Interventions

TypeNameDescription
DRUGCKD-390CKD-390 1 Tablet (48 weeks)
DRUGvireadviread1 Tablet (24 weeks), CKD-390 1 Tablet (from 24 weeks to 48 weeks)

Timeline

Start date
2016-04-01
Primary completion
2017-11-01
Completion
2018-03-01
First posted
2016-06-20
Last updated
2016-06-21

Locations

20 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02805738. Inclusion in this directory is not an endorsement.