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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04639804
• Other study ID #: IN_APA_117
• Status: Completed
• Phase: Phase 1
• Start date: June 6, 2020
• Est. completion date: July 29, 2020

Study information

• Verified date: November 2020
• Source: HK inno.N Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 29, 2020
• Est. primary completion date: July 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tegoprazan
Tegoprazan 50 mg tablet
• Naproxen
Naproxen 500 mg tablet
• Aceclofenac
Aceclofenac 100 mg tablet
• Celecoxib
Celecoxib 200 mg capsule

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of tegoprazan and NSAIDs	Area under the plasma concentration-time curve during a steady-state dosing interval (t) of tegoprazan and NSAIDs	pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7
Primary	Css,max of tegoprazan and NSAIDs	Maximum Plasma Concentration at Steady State of tegoprazan and NSAIDs	pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7