Clinical study to compare the pharmacokinetic characteristics and the safety between Tenelitin tablet 20 mg and Tenelia tablet 20 mg in healthy adult subjects
- Conditions
- Not Applicable
- Registration Number
- KCT0003832
- Lead Sponsor
- Kyung Dong Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
1) Healthy male older than 19 to 45 years at the time of screening
2) Body weight more than 50kg and Body Mass Index(BMI) 18~29 kg/m2
? BMI = (weight [kg])/(height [m])2
3. Subject judged to be eligible by physical examination and interview conducted according to the study protocol. Thus, Subject should not have congenital/chronic disease or pathological symptoms/findings
4. Subject judged to be eligible by clinical tests such as hematology test, blood chemistry test, serum electrolyte test, urine test, Urine Microscopy urine test, serology test performed according to the study protocol
5. Subject who fully understands the clinical trials after in-depth explanation, volunteers to join the clinical trials and signs inform consent
1) Subject currently with or has a history of cardiovascular , respiratory, hepatic, renal, neurological, endocrine, hemato-oncology, psychiatric, urinary diseases that is clinically significant
2) Subject with a history of significant hypersensitivity or clinically significant hypersensitivity reaction to Tenelitin and other drugs (aspirin, antibiotic…etc.)
3) Systolic blood pressure ?100mmHg or ? 150mmHg, diastolic blood pressure?55mmHg or ? 95mmHg
4) The below patient or condition
- Hypopituitarism or adrenal insufficiency
- Malnutrition, starvation, irregular eating, lack of meals or weakness
- Patients with intense muscle movements
5) A person with a history of abdominal surgery or intestinal obstruction
6) Patients who are prone to QT interval prolongation (patients with severe arrhythmia such as bradycardia or patients with past medical history, patients with heart disease such as congestive heart failure, hypokalemia patients, etc.)
7) Subject with the following results in the clinical laboratory tests
- Aspartate Transaminase(AST) or Alanine Transaminase(ALT) > 2 x upper limit of normal range
- Total Bilirubin > 2.0 mg/dl
- CK > 2 x upper limit of normal range
- eGFR < 60 mL/min/1.73m2
8) Subject who takes alcohol > 21 units/week, 1unit=10g=12.5ml of pure alcohol) or can’t stop drinking during the clinical trials
9) Subject who smokes> 10 cigarettes/day or can’t stop smoking during the clinical trials
10) Taking medication involved in other clinical trials within 90 days before the first administration
11) Whole blood donation within 60 days or component blood donation within 30 days before the first administration
12) Taking Prescription drug (ETC) or oriental medicine within two weeks and any OTC within 2 weeks before the first administration
13) Taking metabolizing enzyme inducers or inhibitors such as barbitals within 30 days before the first administration
14) Subject with mental illness or substance abuse
15) Consumption of food which can significantly change the absorption, distribution, metabolism and excretion of a drug within 7 days before the first administration (such as grapefruit or its components)
16)Those who do not agree with the approved method of contraception during the clinical trial
17) Patients judged as inadequate and clinical trials to test self-determined target for any reason.
18) Pregancy, serum/ urine hCG Positive or breasrfeeding female
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Citrulline AUCt , Cmax
- Secondary Outcome Measures
Name Time Method Citrulline of AUC8, tmax, t1/2, Vd/F, CL/F