None listed
Conditions
Interventions
Drug : Single oral administration of the test formulation Daewoong Rabeprazole 20 mg tablet and the reference formulation Pariet 20 mg tablet under fasting conditions in healthy subjects. The study is
Sponsors
Daewoong Bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects aged 19 years or older at the time of screening. 2) Subjects with a Body Mass Index (BMI) between 18 and 30 kg/m² (BMI = weight(kg) / height(m)²) - For males: body weight = 50 kg - For females: body weight = 45 kg 3) Subjects without clinically significant congenital or chronic diseases, and with no abnormal findings of clinical relevance based on medical examination (including, if necessary, EEG, ECG, chest X-ray, upper endoscopy, or gastrointestinal radiography). 4) Subjects who are judged by the investigator (or sub-investigator) to be appropriate for study participation based on diagnostic laboratory tests, including hematology, blood chemistry, serology, and urinalysis, performed according to the characteristics of the investigational product. 5) Subjects who fully understand the nature and procedures of the study, voluntarily decide to participate, and sign the written informed consent form, and agree to comply with study restrictions during the study period. 6) Subjects (and their spouse or partner) who agree to use medically acceptable contraception from the first dosing day until 1 week after the last administration of the investigational product, and agree not to donate sperm or ova during the same period. * Medically acceptable contraception includes: intrauterine device (IUD/IUS), vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, contraceptive sponge), or two simultaneous barrier methods if used with spermicides.
Exclusion criteria
Exclusion criteria: 1) Subjects who have taken enzyme-inducing or enzyme-inhibiting drugs such as barbiturates within 30 days prior to the first dosing, or who have taken any medication that may interfere with this study within 10 days prior to the first dosing. 2) Subjects who have participated in a bioequivalence study or any other clinical trial and received an investigational product within 6 months prior to the first dosing (The “end date” of participation is defined as the last dosing date of the previous trial). 3) Subjects who have donated whole blood within 8 weeks or blood components within 2 weeks prior to the first dosing. 4) Subjects with a history of gastrointestinal surgery that may affect drug absorption (simple appendectomy or hernia repair excluded). 5) Subjects with a history of habitual alcohol consumption within 1 month prior to dosing (more than 21 drinks/week for males or 14 drinks/week for females; 1 drink = 50 mL soju, 250 mL beer, or 30 mL whisky). 6) Subjects who correspond to any of the following: - Known hypersensitivity to this drug, its components, or other benzimidazole derivatives - Known hypersensitivity to penicillin antibiotics - Known hypersensitivity to macrolide antibiotics - Currently taking terfenadine, cisapride, pimozide, or astemizole - Currently taking atazanavir - Currently taking rilpivirine 7) Subjects with a history of clinically significant psychiatric disorders. 8) Subjects who, in the opinion of the investigator (or sub-investigator), are considered unsuitable for participation in this clinical trial for reasons not otherwise specified in the inclusion/exclusion criteria. 9) Female subjects who are pregnant, suspected of being pregnant, or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt (Area Under the Plasma Concentration–Time Curve to the last measurable concentration) ;Cmax (Maximum Plasma Concentration) | — |
Secondary
| Measure | Time frame |
|---|---|
| t1/2 (Terminal Elimination Half-life);AUC8 (Area Under the Curve extrapolated to infinity);AUCt/AUC8 Ratio;Tmax (Time to reach Cmax) | — |
Countries
Korea, Republic of
Contacts
Public ContactSeunghyun Kang
H Plus Yangji Hospital
Outcome results
None listed