Status and phase
Conditions
Treatments
About
This is a phase 1, randomized, parallel-group, single-center study in healthy adult subjects. The study will be conducted in two parts sequentially:
Part 1 is an open-label, two-arm, active-controlled design to evaluate the PK and safety of single oral dose of ETV XR tablet (1.5 mg) in healthy subjects. Part 1 will consist of 16 healthy subjects.
Part 2 is a double-blind, three-arm, placebo-controlled design to evaluate the PK and safety of higher oral doses of ETV XR tablet (3 mg and 6 mg) in healthy subjects. Part 2 will consist of 24 healthy subjects.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subjects will be considered for enrollment in the study if they meet all of the inclusion criteria and none of the exclusion criteria.
Exclusion criteria
A subject meeting any of the following criteria will be excluded from the study:
Primary purpose
Allocation
Interventional model
Masking
40 participants in 5 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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