Status:
UNKNOWN
Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects
Lead Sponsor:
SamA Pharmaceutical Co., Ltd
Conditions:
Healthy
Eligibility:
MALE
19-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is Safety, Pharmacokinetic Study of PRIC
Detailed Description
1. To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup 2. To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup
Eligibility Criteria
Inclusion
- 19 to 45 years old healthy male subject at the screening
- Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study
Exclusion
- Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Subjects with history of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, ear, nose and throat (ENT), respiratory, musculoskeletal, infectious, gastrointestinal, liver, biliary, endocrine, renal, genitourinary, nervous, psychiatric, blood disorders, tumors, fractures or any other conditions
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03826485
Start Date
April 1 2019
End Date
July 31 2019
Last Update
February 1 2019
Active Locations (1)
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1
Asan Medical Center
Seoul, Songpa-gu, South Korea