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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- HK inno.N Corporation
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- AUCτ of tegoprazan and NSAIDs
Study Overview
Brief 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.
Detailed Description
A randomized, open-label, multiple-dose, 6-sequence-arm, 3-period cross-over study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Tegoprazan 50 mg
Multiple doses of tegoprazan alone once daily (QD) for 7 days
Intervention: Tegoprazan (Drug)
NSAIDs
Multiple doses of NSAIDs alone twice daily (BID) for 7 days
Intervention: Naproxen (Drug)
NSAIDs
Multiple doses of NSAIDs alone twice daily (BID) for 7 days
Intervention: Aceclofenac (Drug)
Tegoprazan 50 mg + NSAIDs
Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days
Intervention: Naproxen (Drug)
NSAIDs
Multiple doses of NSAIDs alone twice daily (BID) for 7 days
Intervention: Celecoxib (Drug)
Tegoprazan 50 mg + NSAIDs
Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days
Intervention: Tegoprazan (Drug)
Tegoprazan 50 mg + NSAIDs
Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days
Intervention: Aceclofenac (Drug)
Tegoprazan 50 mg + NSAIDs
Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days
Intervention: Celecoxib (Drug)
Outcomes
Primary Outcomes
AUCτ of tegoprazan and NSAIDs
Time Frame: pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7
Area under the plasma concentration-time curve during a steady-state dosing interval (τ) of tegoprazan and NSAIDs
Css,max of tegoprazan and NSAIDs
Time Frame: pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7
Maximum Plasma Concentration at Steady State of tegoprazan and NSAIDs
Secondary Outcomes
No secondary outcomes reported