NCT04204629

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

A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of HIP1601 40 mg in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	HIP1601 40mg	Single dosing of HIP1601 40mg, PO

Timeline

• Start date: 2020-01-13
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2019-12-19
• Last updated: 2022-11-01

Locations

1 site across 1 country: South Korea