Tegoprazan-Aspirin Drug Interaction in Healthy Adult Male Volunteers

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age19-50
SponsorHK inno.N Corporation

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Aspirin

    Drug

    QD, for 5 days

  • Tegoprazan

    Drug

    QD, for 5 days

  • Tegoprazan + Aspirin

    Drug

    QD, for 5 days

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Aspirin-Tegoprazan SequenceExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Cmax,ss of Aspirin

PK parameter of Aspirin

Time frame
Day 1-Day 5, Day 22-Day 25 up to 24 hours
2

AUCtau,ss of Aspirin

PK parameter of Aspirin

Time frame
Day 1-Day 5, Day 22-Day 25 up to 24 hours
3

Cmax,ss of Tegoprazan

PK parameter of Tegoprazan

Time frame
Day 16-Day 20, Day 22-Day 25 up to 24 hours
4

AUCtau,ss of Tegoprazan

PK parameter of Tegoprazan

Time frame
Day 16-Day 20, Day 22-Day 25 up to 24 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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