NCT03383042

Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects

A Randomized, Open-label, Placebo- and Active- Controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Jeil Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration in healthy male subjects

Conditions

• Anti-Ulcer Agents

Interventions

Type	Name	Description
DRUG	Cohort 1 (JP-1366 A mg)	Drug: JP-1366 A mg or JP-1366 Placebo or Esomeprazole 40 mg
DRUG	Cohort 2 (JP-1366 B mg)	Drug: JP-1366 B mg or JP-1366 Placebo or Esomeprazole 40 mg
DRUG	Cohort 3 (JP-1366 C mg)	Drug: JP-1366 C mg or JP-1366 Placebo or Esomeprazole 40 mg
DRUG	Cohort 4 (JP-1366 D mg)	Drug: JP-1366 D mg or JP-1366 Placebo or Esomeprazole 40 mg
DRUG	Cohort 5 (JP-1366 E mg)	Drug: JP-1366 E mg or JP-1366 Placebo or Esomeprazole 40 mg
DRUG	Cohort 6 (JP-1366 F mg)	Drug: JP-1366 F mg or JP-1366 Placebo or Esomeprazole 40 mg
DRUG	Cohort 7 (JP-1366 G mg)	Drug: JP-1366 G mg or JP-1366 Placebo or Esomeprazole 40 mg
DRUG	Cohort 8 (JP-1366 H mg)	Drug: JP-1366 H mg or JP-1366 Placebo or Esomeprazole 40 mg
DRUG	Cohort 9 (JP-1366 I mg)	Drug: JP-1366 I mg or JP-1366 Placebo or Esomeprazole 40 mg

Timeline

• Start date: 2017-12-22
• Primary completion: 2018-11-23
• Completion: 2019-04-05
• First posted: 2017-12-26
• Last updated: 2019-04-22

Locations

1 site across 1 country: South Korea