Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects

A Randomized, Open-label, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in Healthy Male Subjects

This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers

Primary Outcome Measure:

1. AUClast and Cmax of tegaprazan
2. Gastric pH

Inclusion Criteria:

• 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 Criteria:

• 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