Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers
Study Details
Study Description
Brief Summary
This study aims to evaluate the pharmacodynamics after single oral dosing of tegoprazan, EAPA115 and RAPA115 in healthy volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Evaluation Criteria
-
Pharmacodynamic assessments with intragastric pH
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Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tegoprazan 50 mg Oral administration of Tegoprazan 50 mg tablet once a day |
Drug: Tegoprazan 50 mg
Tegoprazan 50 mg tablet
Other Names:
|
| Active Comparator: EAPA115 Oral administration of EAPA115 once a day |
Drug: EAPA115
EAPA115
|
| Active Comparator: RAPA115 Oral administration of RAPA115 once a day |
Drug: RAPA115
RAPA115
|
Outcome Measures
Primary Outcome Measures
- Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period]
The ratio of duration(Duration %) with pH ≥ 4 over 24 hours
- Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period]
The ratio of duration(Duration %) with pH ≥ 6 over 24 hours
- Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period]
Median pH
- Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period]
Mean pH
- Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period]
Baseline pH and changes in pH after the administration of investigational products (change of duration %, change of mean pH, change of median pH)
- Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period]
The ratio of duration(Duration %) with pH ≥ 4 during nocturnal period* (*12 hours after administration of investigational product)
- Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period]
The ratio of duration(Duration %) with pH ≥ 6 during nocturnal period* (*12 hours after administration of investigational product)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adults aged 19 to 65 years (not inclusive) at the time of signing the informed consent form (ICF).
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Body mass index (BMI) ≥ 17.5 and < 30.5 kg/m2 with a body weight ≥ 45 kg at screening. Body mass index (kg/m2) = weight (kg)/height (m)^2
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Confirmed as H. pylori negative
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A subject without any congenital or chronic disease within 3 years, and has no medical examination result as pathological symptoms or signs.
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A subject determined eligible for this study based on the screening test such as clinical laboratory tests (hematology test, chemistry test, urine test, virus/bacteria test, etc.), vital signs, and electrocardiogram.
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A subject who is fully informed of the purpose and content of the study and agrees to participate in the study on its own will and signs the consent form approved by the Institutional Review Board (IRB) of the Seoul National University Hospital, prior to participate in the study.
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A subject who has the ability and willingness to participate throughout the whole study period.
Exclusion Criteria:
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A subject with clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychical, neurologic, or immunologic diseases (except for simple dental past history such as tartar, impacted tooth, or wisdom tooth) or evidence.
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A subject with a history of gastrointestinal disorders (esophageal diseases such as esophageal achalasia or esophageal stricture, Crohn's disease) or surgery (except for simple appendectomy, herniotomy, and tooth extraction surgery) that may affect the absorption of drugs.
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A subject with the *17 allele of CYP2C19 (Ultrarapid metabolizer).
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A subject with AST and ALT levels exceeding 3 times of the upper limit of the reference range in the screening test.
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A subject with a history of excessive caffeine (> 5 units/day) or regular alcohol consumption exceeding 210 g/week within 6 months of screening test. (1 glass of beer (5%) (250 mL) = 10 g, 1 shot of soju (20%) (50 mL) = 8 g, 1 glass of wine (12%) (125 mL) = 12 g)
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A subject who participated in other clinical trial or bioequivalence study and administered the study medication within 6 months prior to the first administration of the investigational product of this study.
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A subject with significant alcohol or drug abuse within a year of screening test.
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A subject who administered drugs that significantly induce or inhibit drug metabolizing enzymes within 30 days prior to the first administration of the investigational product of this study.
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A subject who smoked cigarettes more than 20 per day within 6 months of screening test.
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A subject who administered prescribed drug or over-the-counter drug within 10 days prior to the first administration of the investigational product of this study.
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A subject who has donated whole blood within 2 months or those who donated the component blood within 1 month prior to the first administration of the investigational product of this study.
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A subject who has hypersensitivity to the investigational product of this study, benzimidazoles, penicillin and macrolide and its related medical history.
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A subject with rare genetic problems such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.
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Pregnant or nursing women
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A subject who cannot use reliable contraception during the entire period of the clinical trial (e.g, condom use, intrauterine device, tubal ligation, cervical cap, contraceptive diaphragm, etc.).
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A subject who is judged by the investigator to be ineligible to participate in the test.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital, Clinical Trial Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- HK inno.N Corporation
Investigators
- Principal Investigator: In-Jin Jang, MD, PhD, Seoul National University Hospital, Dept. of Clinical Pharmacology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CJ_APA_115