drugset
drugset / Trial / NCT03882112

Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Male Subjects

NCT03882112 ↗

Phase 1 Completed 24 enrolled Hanmi Pharmaceutical Company Limited
RandomizedCrossoverOpen-labelTreatment

Summary

Primary objective \- To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition. Secondary objectives * To explore food effect on the pharmacodynamics (PD) of single oral dose of HIP1601 in healthy subjects under fed or fasting condition. * To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

Timeline

Start
2019-04-17
Primary completion
2019-08-28
Completion
2019-08-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Esomeprazole Small molecule 40 mg Oral

Indications

No indication recorded.