Status:
COMPLETED
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Anti-Ulcer Agents
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration in healthy male subjects
Eligibility Criteria
Inclusion
- Healthy adult males aged between 19 and 50 at screening
- Weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Exclusion
- Subject has clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Subject has gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- Subject has been Helicobacter pylori positive
- AST (SGOT) and ALT (SGPT) \> 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- Subject has anatomical disability in insertion and maintenance of pH meter catheter
Key Trial Info
Start Date :
December 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2019
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT03383042
Start Date
December 22 2017
End Date
April 5 2019
Last Update
April 22 2019
Active Locations (1)
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1
Seoul National University Hospital(SNUH)
Seoul, Jongno-Gu, South Korea, 110-744