A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Entecavir Extended Release (XR) in Healthy Subjects
Status:
Completed
Trial end date:
2018-06-20
Target enrollment:
Participant gender:
Summary
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.