Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT04639804
- Lead Sponsor
- HK inno.N Corporation
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tegoprazan 50 mg + NSAIDs Aceclofenac Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days NSAIDs Celecoxib Multiple doses of NSAIDs alone twice daily (BID) for 7 days NSAIDs Naproxen Multiple doses of NSAIDs alone twice daily (BID) for 7 days Tegoprazan 50 mg Tegoprazan Multiple doses of tegoprazan alone once daily (QD) for 7 days NSAIDs Aceclofenac Multiple doses of NSAIDs alone twice daily (BID) for 7 days Tegoprazan 50 mg + NSAIDs Tegoprazan Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days Tegoprazan 50 mg + NSAIDs Naproxen Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days Tegoprazan 50 mg + NSAIDs Celecoxib Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days
- Primary Outcome Measures
Name Time Method AUCτ of tegoprazan and NSAIDs 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 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of