Phase 1 Clinical Trial to Evaluate Drug-drug Interactions among JP-1366, Amoxicillin, and Clarithromycin in Healthy Volunteers
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0005681
- Lead Sponsor
- Onconic Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
1. Individuals who signed the written informed consent form approved by the IRB to participate in this study of their own free will after being sufficiently explained about the objectives, content, and characteristics of the investigational product before participation in the clinical trial
2. Healthy adults aged over 19 years old at the time of the screening
3. Male subjects who weigh at least 50 kg and female subjects who weight at least 45 kg, and subjects with a body mass index(BMI) between and including 18.0 and 30.0
1. Medical History
1) Subjects with clinically significant medical history pertaining to the liver , kidneys, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hematologic system/tumor, and cardiovascular system (heart failure, orthostatic hypotension, etc.)
2) Subjects with medical histories related to gastrointestinal tracts that can affect the absorption of the investigational product (e.g., Crohn’s disease, ulcerative diseases, etc.) and surgery (exceptions for appendectomy, hernia surgery, endoscopic polypectomy, hemorrhoid, rectal fissure, and fistula surgery
3) Subjects who had galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
2. Allergy, drug hypersensitivity and drug abuse
1) Subjects with a clinically significant allergic disease (excluding minor allergic rhinitis that does not require administration)
2) Subjects who has the potential to drug hypersensitivity to the ingredients IP (Sunset Yellow FCF), anti-ulcerants, penicillin, cephem, macrolide, antibiotics, and other drugs (aspirins, antibiotics, etc.)
3) Subjects who has a history of drug abuse (especially a central nervous system drug, such as sleeping pills, central agonist control, ophthalmology, or psychotropic drugs) or who has tested positive for drug screening (Amphetamines, barbiturates, cocaine, opiates, canabinoides, and benzodiazepines)
3. Clincial Test
1) Vital Sign
-Systolic blood pressure > 150 mmHg or < 90 mmHg, diastolic blood pressure > 100 mmHg or < 50 mmHg in the vital sign measurement while sitting after at least 3 minutes of resting
2) Subjects deemed unsuitable as subjects in the screening test
- ALT, AST, Total bilirubin > 2 times the ULN
-e-GFR < 60 mL/min/1.73m2 (CKD-EPI method)
-HBsAg, HCV Ab, HIV Ab, Syphilis regain test (RPR) positive results
3) Subjects considered to have clinically significant abnormal results in the screening tests (medical history, vital sign measurement, 12-ECG (Atrial fibrillation, ventricular tachycardia etc.)
4. Concomitant Medication/Mill
1) Subjects who took induction or inhibition drug of metablization within 1 month before the scheduled investigational product administration date
2) Subjects who took medication (prescription drugs, nonprescription drugs, herbal medicine, and nutritional supplements (vitamins, etc.)) within 2 weeks before the scheduled investigational product administration date (however, when considered to not affect the subject’s safety and study results by the investigator, the subject may participate)
3) Subjects who participated in a different clinical trial within 180 days of the scheduled investigational product administration date and had experience being administered the investigational product(exception for when the investigational product was not administered)
4) Subjects who cannot be prohibited from a diet (especially grapefruit juice and caffeine) that can affect the absorption, distribution, metabolism, and excretion of the drug from 3 days before the first investigational product administration to until the last visit
5. Blood donation and transfusion
1) Subjects who donated whole blood within 8 weeks before the screening, underwent apheresis blood donation within 4 weeks (plasma, platelet)
2) Subjects who received blood transfusion within 4 weeks
6. Pregnancy and contraception
1) Pregnant women who are positive or breast-feeding pregnancy tests
2)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax,ss, AUCt of JP-1366, Amoxicillin, Clarithromycin
- Secondary Outcome Measures
Name Time Method Tmax, t1/2, CLss/F, Vdss/F of JP-1366, Amoxicillin, Clarithromycin, 14-OH Clarithromycin;Safety Assessment