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

• Status: Completed
• Trial end date: 2020-07-29
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: HK inno.N Corporation
• Treatments: Aceclofenac; Celecoxib; Naproxen

Criteria

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.