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

NCT03383042 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2019-04-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jeil Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-22
Primary Completion
2018-11-23
Completion
2019-04-05

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03383042 on ClinicalTrials.gov