A Phase 1 Clinical Trial to Explore Pharmacokinetics, Pharmacodynamics and Safety After Twice-daily Dosing of Tegoprazan Tablets in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Tegoprazan dose B or placebo
- Conditions
- Healthy
- Sponsor
- HK inno.N Corporation
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics Evaluation
- Last Updated
- 5 years ago
Overview
Brief Summary
The main purpose of this study is to explore the pharmacokinetics, pharmacodynamics and safety after twice-daily dosing of tegoprazan tablets in healthy subjects.
Detailed Description
* To explore the pharmacokinetics, pharmacodynamics and safety in accordance with the dose escalation when tegoprazan is given orally twice daily for 3 days in healthy subjects. * To compare the pharmacodynamics and safety of tegoprazan oral administration and esomeprazole infusion for 24 hours
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects aged 19 to 45(inclusive) years at screening.
- •Subjects with body mass index (BMI) in the range of 18.5 kg/m\^2 to 28.0 kg/m\^2(inclusive)
- •Subjects who voluntarily agreed to participate in the study after being fully informed of the purpose, content, and characteristics of the investigational product(IP) prior to the study participation.
Exclusion Criteria
- •Past medical history
- •Subjects who are determined by the investigator to have clinically significant history or disease related to the liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system, urinary system and cardiovascular system including cardiac arrhythmia.
- •Subjects who are determined by the investigator to have past history of gastrointestinal diseases (ex.: gastritis, GERD, Crohn's disease, ulcers etc.) or abdominal surgery (except simple appendectomy or herniotomy) that may affect the IP absorption.
- •Diagnostic test and electrocardiogram (ECG)
- •If H. pylori test result is positive at screening
- •If the AST or ALT value is more than 1.25 times the upper limit of normal under the screening test
- •If the total bilirubin value is more than 1.5 times the upper limit of normal under the screening test
- •If the eGFR calculated by CKD-EPI formula is less than 80 mL/min at screening
- •Subjects showing clinically significant abnormalities on ECG at screening
- •Allergy and drug abuse
Arms & Interventions
T2
Tegoprazan B mg or placebo
Intervention: Tegoprazan dose B or placebo
T1
Tegoprazan A mg or placebo
Intervention: Tegoprazan dose A or placebo
T3
Tegoprazan C mg or placebo
Intervention: Tegoprazan dose C or placebo
T4
Tegoprazan D mg or placebo
Intervention: Tegoprazan dose D or placebo
Outcomes
Primary Outcomes
Pharmacokinetics Evaluation
Time Frame: Up to 24 hours
Vdss/F of Tegoprazan
Pharmacokinetic Evaluation
Time Frame: Up to 24 hours
Css,avg of Tegoprazan and M1
Secondary Outcomes
- Pharmacodynamics Evaluation(24 hours)