Status:
COMPLETED
Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers
Detailed Description
Primary Outcome Measure: 1. AUClast and Cmax of tegaprazan 2. Gastric pH
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
- Helicobacter pylori negative
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 :
March 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03863938
Start Date
March 27 2019
End Date
June 25 2019
Last Update
August 22 2019
Active Locations (1)
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1
Seoul National University Hospital, Clinical Trial Center
Seoul, South Korea