None listed
Conditions
Interventions
Drug : - IP: J2H-1702
- Oral Medication
- Dose
- Amg, Bmg
Sponsors
J2H Biotech
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Healthy females aged = 19 and = 45 years 2) Subjects with a body mass index (BMI) = 18.0 to = 27.0 kg/m2 3) Subjects confirmed to be clinically healthy based on the medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate clinical laboratory tests 4) Agree to use dual contraceptive methods and not to donate eggs 5) Voluntarily agree to participate in the study
Exclusion criteria
Exclusion criteria: 1) A subject who had or has the disease corresponding to clinically significant liver, etc. 2) A subject with a history of gastrointestinal diseases or surgery 3) A subject who has a history of clinically significant hypersensitivity to drugs containing 11ß-HSD1 inhibitor 4) A subject who has genetic problems such as galactose intolerance, Lap galactose intolerance, Lap lactase deficiencies, or glucose ·galactose malabsorptivity, etc. 5) One who has drug abuse and one who is positive response in urine drug screening tests 6) A subject with abnormal vital signs at the screening visit 7) A subject who has participated in another clinical trial or bioequivalence test 8) A subject who donated whole blood or the ingredient, or received blood transfusion 9) A subject who took drug metabolizing enzyme-inducing and inhibitory drugs 10) A subject who consumes grapefruit/caffeine-containing food 11) A subject who took any prescription drug or herbal medicine or took any Over The Counter Drug (OTC) 12) High caffeine intaker, high alcohol intaker or excessive smoker 13) A subject who cannot eat meals provided by the Clinical Trial institution. 14) A subject who participated in this trial and were administered the investigational product. 15) A subject who is positive for serum test 16) A pregnanct or breast-feeding subject 17) A subject who the investigator deems inappropriate for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital sign, Physical exam, 12-lead ECG, Clinical laboratory tests, Drug screen and serology etc. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax, AUClast, AUCinf, Tmax, t1/2, fe, CLR, CL/F, Vz/F;Serum cortisol- ?Emax and ?AUEClast/ 24-hour urinary free cortisol- ?Eufc | — |
Countries
Korea, Republic of
Contacts
Public ContactSangWon Lee
Hanyang University Seoul Hospital
Outcome results
None listed