The Evaluation of Safety, Tolerability and Pharmacokinetics of Stroke Targeting Drug in Healthy Volunteers

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in healthy male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• 19~55 years healthy male

• BMI measurement 20kg/m²~27kg/m²

• 90 ≤ SBP<140(mmHg) 60 ≤ DBP<100(mmHg) 45 ≤ Pulse rate<100(bpm)

• Signed the informed consent from to participate voluntarily and to comply with the trial requirements

• For a follow-up visit and during the study period, blood samples and availability

Exclusion Criteria:

• History of clinically significant hepatic, gastrointestinal, pulmonary, musculoskeletal, endocrine, psychiatric, hematooncologic, cardiovascular (Specially asthma, obstructive pulmonary disease, peptic ulcer)

• History of skin disease of graft affecting absorption of the drug

• History of drug abuse

• Positive urine drug screening

• Administrated investigational product in a previous clinical trial within 60 days of the screening test

• Donated blood within 60 days prior to screening test