Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers

An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Tegoprazan and Non-steroidal Anti-inflammatory Drugs (NSAIDs) After Multiple Oral Dosing in Healthy Male Volunteers

This study aims to evaluate the pharmacokinetic (PK) interaction between tegoprazan and non-steroidal anti-inflammatory drugs (NSAIDs) after given each alone and in their combination in healthy male adults.

A randomized, open-label, multiple-dose, 6-sequence-arm, 3-period cross-over study

Inclusion Criteria:

• Healthy adult aged ≥ 19 and < 55 year-old at screening
• Body mass index (BMI) ≥ 19.0 kg/m2 and < 27.0 kg/m2 with a body weight ≥ 55 kg at screening.

Exclusion Criteria:

• History or evidence of clinically significant disease
• History of GI disease or surgery that may affect the absorption of a drug
• Laboratory test result which falls into the following values( ALT or AST > 2 × upper limit of normal (ULN))
• History of regular alcohol consumption exceeding 210 g/week within 6 months
• Daily use of ≥ 20 cigarettes within 6 months
• Has taken any investigational agent within 6 months prior to the first dose of IMP
• Subjects who are considered ineligible to participate in this study at the discretion of the investigator.