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drugset / Trial / NCT05665283

A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions

NCT05665283 ↗

Phase 1 Completed 32 enrolled Xcovery Holdings, Inc.
RandomizedCrossoverOpen-labelOther

Summary

This is an open-label, Phase I single dose 2-part, crossover bioequivalence study under fasted conditions. The trial is designed to evaluate the pharmacokinetic parameters between single doses of 100mg ensartinib capsules manufactured by two different processes.

Timeline

Start
2022-11-29
Primary completion
2023-01-18
Completion
2023-08-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ensartinib Small molecule 100 mg Oral

Indications

No indication recorded.