None listed
Conditions
Interventions
Drug : A randomized, open-label, single dose, 3-period, 3-sequence crossover study to compare the pharmacokinetics and safety/tolerability of “BS-105 enteric-coated tablet A” or “BS-105 enteric-coated
BS-105 enteric-coated tablet A =>
BS-105 enteric-coated tablet B
Group 2: BS-105 enteric-coated tablet A =>
BS-105 enteric-coated tablet B =>
Noxafil
Group 3: BS-105 enteric-coated tablet B =>
Noxafil =>
BS-105 enteric-coated tablet A
Sponsors
Bio-Synectics
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Healthy male, 19 years= Age = 50 years at the time of screening 2. 55.0 kg = Body weight = 90 kg and 18.0 kg/m² = BMI = 27.0 kg/m² * BMI = Body weight(kg)/{Height(m)}² 3. Subject who had decided to participate in the clinical trial with willingness after fully understanding the clinical trial after in-depth explanation and signed an informed consent form before participating in the screening procedure 4. Subject who has no congenital or chronic diseases and no abnormal symptoms or signs based on medical examinations (if needed, EEG, ECG, thoracoscopy and gastroscopy, or gastrointestinal radiology examination) 5. Subject who is suitable for the clinical trial determined by investigator's judgement based on physical examination, laboratory tests, paper interview, etc.
Exclusion criteria
Exclusion criteria: 1. Subject who has a clinically significant hepatic, renal, nervous, respiratory, endocrine, haemato-oncology, cardiovascular, urinary, or psychiatric diseases or who has a medical history of these diseases 2. Subject who has or has a history of gastrointestinal diseases(except gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease)or surgeries(except for simple appendicitis or hernia) which can affect the pharmacokinetics and safety of investigational products 3. Subject who has hypersensitivity to posaconazole and any other drugs(aspirin, antibiotics, and so on) or has a history of clinically significant hypersensitivity 4. Subject who is Hepatitis B, Hepatitis C, or HIV- positive 5. Subject who had following results after examinations 5.1) Total bilirubin, AST(GOT). ALT(GPT) > 1.5 x upper limit of normal range at the time of screening 5.2) Systolic blood pressure(SBP) < 90 mmHg or SBP>150 mmHg, Diastolic blood pressure(DBP) < 50 mmHg or DBP>95 mmHg), or pulse rate <45 beats/min or pulse rate >100 beats/min at the time of screening (Vital signs measured in a seated position after resting more than 5 minutes) 5.3) QTc>450 msec, PRinterval>200 msec, QRSinterval>120 msec at ECG test 5.4) Other clinically significant findings 6. Subject who has a history of drug abuse 7. Subject who took (However, if the other conditions are reasonable according to the judgment of the investigator, the subject can participate in the clinical trial) or is expected to take any ETC(Ethical Drug) or oriental medicine within 2 weeks before the first dosing 8. Subject who took(However, if the other conditions are reasonable according to the judgment of the investigator, the subject can participate in the clinical trial) or is expected to take any OTC(Over-the-counter Drug), health functional food, vitamin within 1 week before the first dosing 9. Subject who took medicines that are known to induce or inhibit drug metabolizing enzymes, including barbiturates, within 1 month before the first dosing 10. Subject who took any other investigational product by participating in other clinical trials within 6 months before the first dosing 11. Subject who has donated whole blood or blood components within 2 months or 1 month, respectively, or has been transfused blood within 1 month before the first dosing 12. Subject who takes excessive caffeine (more than 5 units/day) or continually drinks alcohol (more than 21 units/week, 1unit = 10 g of pure alcohol), or cannot stop drinking alcohol during hospitalization period 13. Subject who takes or cannot stop taking food containing grapefruit from 24 hours before hospitalization and until being discharged from the hospital 14. Subject who cannot stop taking food containing caffeine (e.g. coffee, tea(black tea, green tea, etc.), carbonated beverage, coffee flavored milk, or energy drink, etc.) from 24 hours before hospitalization and until being discharged from the hospital 15. Subject who cannot perform clinically acceptable contraception during the clinical trial 16. Subject who is inappropriate for participating in the clinical trial by the judgement of the investigator based on laboratory test results or any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast, Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf, Tmax, t1/2, CL/F, Vd/F | — |
Countries
Korea, Republic of
Contacts
Public ContactEunsol Yang
Seoul National University Hospital
Outcome results
None listed