A study to compare the pharmacokinetics and safety/tolerability of BS-105 enteric-coated tablet A” or BS-105 enteric-coated tablet B” of Bio-Synectics to original drug in healthy male subjects (Pilot study)
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0004007
- Lead Sponsor
- Bio-Synectics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 9
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUClast, Cmax
- Secondary Outcome Measures
Name Time Method AUCinf, Tmax, t1/2, CL/F, Vd/F