NCT03882112

Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Male 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: 24 (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 (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.

Conditions

• Heathy Volunteer

Interventions

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

Timeline

• Start date: 2019-04-17
• Primary completion: 2019-08-28
• Completion: 2019-08-28
• First posted: 2019-03-20
• Last updated: 2019-09-06

Locations

1 site across 1 country: South Korea