A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers

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 Volunteers

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 volunteers

• 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 tolerability of multiple oral dose of tegoprazan in healthy male volunteers.

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

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