About this trial
This Clinical Trial Aims to Evaluate the PK/PD Drug-Drug Interaction and Safety/Tolerability of Tegoprazan and Aspirin in Healthy Adult Male Volunteers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy male adult volunteers aged ≥19 years and ≤50 years at the time of screening
Participants who weigh ≥50.0 kg and ≤90.0 kg at the time of screening and have a body mass index (BMI, Body Mass Index) of ≥18.5 kg/m² and ≤29.9 kg/m²
Participants who, after receiving a sufficient explanation of and fully understanding this clinical trial, voluntarily decide to participate and provide written consent to comply with the precautions
Participants who are determined to be negative in the Helicobacter pylori Antibody test
Disqualifiers
Participants who have or have a history of clinically significant hepatobiliary diseases (e.g., severe hepatic impairment or viral hepatitis), renal diseases (e.g., severe renal impairment), neurological diseases, immune system disorders, respiratory diseases, gastrointestinal diseases, endocrine disorders, hematologic or neoplastic diseases, cardiovascular diseases (e.g., cardiac failure or Torsade de pointes), urinary system disorders, psychiatric disorders (e.g., mood disorder or obsessive-compulsive disorder), sexual dysfunction, or other relevant diseases
Participants who have a history of gastrointestinal diseases (e.g., Crohn's disease, ulcer, gastritis, gastric spasm, or gastroesophageal reflux disease) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the evaluations of the safety, pharmacokinetics, and pharmacodynamics of the investigational product
Participants who have hypersensitivity to P-CAB (Potassium-Competitive Acid Blocker), drugs of the same class, or any other drugs (e.g., Aspirin or other salicylates, antibiotics, or benzimidazole anthelmintics), or who have a history of clinically significant hypersensitivity
Participants with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Trial design
Single group
Treatments tested in this trial
Aspirin
DrugQD, for 5 days
Tegoprazan
DrugQD, for 5 days
Tegoprazan + Aspirin
DrugQD, for 5 days
Treatment groups
Trial outcomes
Primary outcomes
Cmax,ss of Aspirin
PK parameter of Aspirin
AUCtau,ss of Aspirin
PK parameter of Aspirin
Cmax,ss of Tegoprazan
PK parameter of Tegoprazan
AUCtau,ss of Tegoprazan
PK parameter of Tegoprazan
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: