Phase 1 Clinical Trial to Explore Pharmacokinetics, Pharmacodynamics and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Famotidine 20mg
- Conditions
- Healthy
- Sponsor
- HK inno.N Corporation
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Cmax of tegoprazan and tegoprazan's metabolite M1
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of this study is to explore pharmacokinetics, pharmacodynamics, and safety of tegoprazan 12.5 mg in healthy subjects when orally administered as a single dose or as multiple doses twice daily.
Detailed Description
The secondary objectives of this study are * To compare pharmacokinetics and pharmacodynamics of tegoprazan 12.5 mg in healthy subjects between oral multiple-dose administration twice daily for 1 day and oral single-dose administration. * To evaluate pharmacokinetics and pharmacodynamics of tegoprazan 12.5 mg administered orally twice daily for 14 days in healthy subjects in comparison with tegoprazan 25 mg administered orally once daily for 14 days in healthy subjects. * To evaluate pharmacodynamics of tegoprazan 12.5 mg administered orally twice daily for 14 days or tegoprazan 25 mg administered orally once daily for 14 days in healthy subjects in comparison with famotidine 20 mg administered orally twice daily for 14 days in healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adults aged ≥ 19 years to ≤ 45 years at the time of screening testing
- •Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 28.0 kg/m2 (BMI = weight (kg) / height (m)2)
- •Those who have been fully informed of study purpose and procedures, properties of the investigational products(IPs), etc. and have voluntarily decide to participate in this study and signed an informed consent form (ICF), prior to participation in the study
Exclusion Criteria
- •Medical history
- •Previous history or presence of clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, urinary and cardiovascular (including cardiac arrhythmia) disorders in the judgment of the investigator
- •Previous history of gastrointestinal diseases (e.g., gastritis, gastrospasm, gastroesophageal reflux disease (GERD), Crohn's disease, ulcers, etc.) or abdominal surgery (excluding simple appendectomy or hernia surgery) which may affect drug absorption in the judgment of the investigator
- •Presence of anatomical disorders that make it difficult to insert and maintain a catheter for intragastric pH measurement, or expected intolerance to catheterization for intragastric pH measurement
- •Hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Clinical laboratory tests and electrocardiogram (ECG)
- •AST or ALT value ≥ 1.5 x upper limit of normal (ULN) as a result of clinical laboratory testing at screening
- •Total bilirubin value ≥ 2.0 x upper limit of normal (ULN) as a result of clinical laboratory testing at screening
- •eGFR value calculated using the CKD-EPI formula \< 80 mL/min as a result of clinical laboratory testing at screening
- •Any clinically significant abnormality as a result of ECG at screening
Arms & Interventions
Group C
Famotidine 20mg
Intervention: Famotidine 20mg
Group A
Tegoprazan 12.5mg
Intervention: Tegoprazan 12.5mg
Group B
Tegoprazan 25mg
Intervention: Tegoprazan 25mg
Outcomes
Primary Outcomes
Cmax of tegoprazan and tegoprazan's metabolite M1
Time Frame: Pre-dose(0 hour) up to 24 hours on Day 1
Pharmacokinetic evaluation (Day 1)
t1/2β of tegoprazan and tegoprazan's metabolite M1
Time Frame: Pre-dose(0 hour) up to 24 hours on Day 1
Pharmacokinetic evaluation (Day 1)
Accumulation index of tegoprazan
Time Frame: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14
Pharmacokinetic evaluation (Day 14)
Tmax of tegoprazan and tegoprazan's metabolite M1
Time Frame: Pre-dose(0 hour) up to 24 hours on Day 1
Pharmacokinetic evaluation (Day 1)
AUC0-∞ of tegoprazan and tegoprazan's metabolite M1
Time Frame: Pre-dose(0 hour) up to 24 hours on Day 1
Pharmacokinetic evaluation (Day 1)
AUC0-t of tegoprazan and tegoprazan's metabolite M1
Time Frame: Pre-dose(0 hour) up to 24 hours on Day 1
Pharmacokinetic evaluation (Day 1)
CL/F of tegoprazan
Time Frame: Pre-dose(0 hour) up to 24 hours on Day 1
Pharmacokinetic evaluation (Day 1)
Vd/F of tegoprazan
Time Frame: Pre-dose(0 hour) up to 24 hours on Day 1
Pharmacokinetic evaluation (Day 1)
AUCtau,ss of tegoprazan and tegoprazan's metabolite M1
Time Frame: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14
Pharmacokinetic evaluation (Day 14)
Tmax,ss of tegoprazan and tegoprazan's metabolite M1
Time Frame: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14
Pharmacokinetic evaluation (Day 14)
t1/2β,ss of tegoprazan and tegoprazan's metabolite M1
Time Frame: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14
Pharmacokinetic evaluation (Day 14)
CLss/F of tegoprazan
Time Frame: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14
Pharmacokinetic evaluation (Day 14)
Vdss/F of tegoprazan
Time Frame: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14
Pharmacokinetic evaluation (Day 14)
Css,max of tegoprazan and tegoprazan's metabolite M1
Time Frame: Pre-dose(morning) (-12, 0 hour) up to 24 hours on Day 14
Pharmacokinetic evaluation (Day 14)
Css,min of tegoprazan and tegoprazan's metabolite M1
Time Frame: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14
Pharmacokinetic evaluation (Day 14)
Css,avg of tegoprazan and tegoprazan's metabolite M1
Time Frame: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14
Pharmacokinetic evaluation (Day 14)
Fluctuation of tegoprazan
Time Frame: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14
Pharmacokinetic evaluation (Day 14)
Secondary Outcomes
- 24-hour, daytime and nighttime mean pH(24 hours on Day -1, Day 1, Day 7, and Day 14)
- 24-hour, daytime and nighttime median pH(24 hours on Day -1, Day 1, Day 7, and Day 14)
- 24-hour, daytime and nighttime TpH>3(%)(24 hours on Day -1, Day 1, Day 7, and Day 14)
- 24-hour, daytime and nighttime TpH>4(%)(24 hours on Day -1, Day 1, Day 7, and Day 14)
- 24-hour, daytime and nighttime Δ TpH>3(%)(24 hours on Day -1, Day 1, Day 7, and Day 14)
- 24-hour, daytime and nighttime Δ TpH>4(%)(24 hours on Day -1, Day 1, Day 7, and Day 14)
- 24-hour, daytime and nighttime Δ mean pH(24 hours on Day -1, Day 1, Day 7, and Day 14)
- 24-hour, daytime and nighttime Δ median pH(24 hours on Day -1, Day 1, Day 7, and Day 14)