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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Aceclofenac; Drug: Naproxen; Drug: Tegoprazan; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04639804

IN_APA_117

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Tegoprazan 50 mg

Active Comparator group

Description:

Multiple doses of tegoprazan alone once daily (QD) for 7 days

Treatment:

Drug: Tegoprazan

NSAIDs

Active Comparator group

Description:

Multiple doses of NSAIDs alone twice daily (BID) for 7 days

Treatment:

Drug: Celecoxib

Drug: Aceclofenac

Drug: Naproxen

Tegoprazan 50 mg + NSAIDs

Active Comparator group

Description:

Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days

Treatment:

Drug: Celecoxib

Drug: Tegoprazan

Drug: Aceclofenac

Drug: Naproxen