KCT0002205Completed未知
A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of CANDEAMLO Tablet 16/10mg in Healthy Adult Male Subjects
Shin Poong Pharm0 sites46 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 46
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19(Year) to 45(Year) (—)
- Sex
- Male
Inclusion Criteria
- •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
Exclusion Criteria
- •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 amlodipine, candesartan, drugs based on Dihydropyridine and other drugs (aspirin, antibiotic…etc.)
- •3) Systolic blood pressure ?100mmHg or ? 150mmHg, diastolic blood pressure?55mmHg or ? 95mmHg
- •4) Subject with a history of gastrointestinal disease (i.e. Crohn’s disease, ulcer…etc.) or gastrointestinal surgery (not including, simple appendectomy or hernia surgery) that can affect drug absorption
- •5) Subject with the following results in the clinical laboratory tests
- •- Aspartate Transaminase(AST) or Alanine Transaminase(ALT) > 1.5 x upper limit of normal range
- •- Total Bilirubin > 1.5 x upper limit of normal range
- •- Abnormal Serum Potassium Level: <3.5mEq>/L or >5.5 mEq/L
- •- Creatinine clearance: <50mL>/min with kidney failure
- •[Cockcroft-Gault Glomerular filtration rate (GFR) = (140-age) * (Wt in kg) / (72 * Cr)]
- •6) Subject with hereditary angioedema or a history of angioedema when treated with ACE(Angiotensin-Converting enzyme) inhibitor or ARB(Angiotensin II Receptor Blocker) therapy
- •7) Subject who takes alcohol > 21 units/week, 1unit=10g=12.5ml of pure alcohol) or smokes> 10 cigarettes/day or can’t stop drinking during the clinical trials
- •8) Taking medication involved in other clinical trials within 60 days before the first administration
- •9) Whole blood donation within 60 days or component blood donation within 30 days before the first administration
- •10) Taking metabolizing enzyme inducers or inhibitors such as barbitals within 28 days before the first administration
- •11) Taking Prescription drug (ETC) or oriental medicine within two weeks and any OTC within 1 week before the first administration
- •12) Subject with mental illness or substance abuse
- •13) 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)
- •14) Patients judged as inadequate and clinical trials to test self-determined target for any reason
Investigators
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