NCT03372850

Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations

A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers

Detailed description

This study is a 2-part study, where in Part A, the 40 mg dose will be performed followed by the 20 mg dose in Part B.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HIP1601	Test Drug
DRUG	HGP1705	Reference Drug

Timeline

• Start date: 2018-02-15
• Primary completion: 2018-06-15
• Completion: 2018-06-15
• First posted: 2017-12-14
• Last updated: 2018-01-17

Locations

1 site across 1 country: South Korea