Status:
COMPLETED
A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers
Lead Sponsor:
HK inno.N Corporation
Conditions:
Pharmacodynamics
Healthy Male Volunteers
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunte...
Detailed Description
* To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers. * To evaluate the safety and tole...
Eligibility Criteria
Inclusion
- Healthy adult males aged ≥ 19 years and ≤ 50 years
- Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
Exclusion
- Presence or history of clinically significant diseases
- Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)
- Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
- Serologic test positive
- Abnormal obstacle to insertion and maintenance of pH meter catheter
- History of drug abuse
- Excessive caffeine intake or persistent alcohol intake
- Not use of a medically acceptable method of contraception
Key Trial Info
Start Date :
December 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03378284
Start Date
December 10 2017
End Date
January 16 2018
Last Update
March 30 2018
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea