Status:
UNKNOWN
Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multip...
Detailed Description
This study is a 2-part study, where in Part A, the 40 mg dose will be performed followed by the 20 mg dose in Part B.
Eligibility Criteria
Inclusion
- Age 19\~50 years in healthy male volunteers
- BMI is more than 18 kg/m\^2 , no more than 27.0 kg/m\^2
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2018
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03372850
Start Date
February 15 2018
End Date
June 15 2018
Last Update
January 17 2018
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea