drugset / Trial / NCT02108418

Study to Evaluate the PK, Relative Bioavailability and Safety of TG-2349 With Single Oral Dose Under Fed Condition in Healthy Volunteers

NCT02108418

Phase 1 Completed 24 enrolled TaiGen Biotechnology Co., Ltd.
RandomizedCrossoverOpen-label

Summary

1. To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers. 2. To evaluate the safety and tolerability of TG-2349 in healthy volunteers. 3. To evaluate the ethnic differences in PK and safety between East Asian and Caucasian volunteers.

Timeline

Start
2014-04
Primary completion
2014-06
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Furaprevir Small molecule 400 mg Oral

Indications

No indication recorded.