Healthy Male Subjects Clinical Trial
primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and Atorvastatin
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 19 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Adult healthy males 20 to 45 years at screening. - BMI 18-29 kg/m2 Exclusion Criteria: - History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease - Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin - Hypotension (DBP = 100 mmHg or SBP = 95mmHg) and hypertension (SBP = 150 mmHg or DBP = 95 mmHg) - Gastrointestinal disease affected the absorption of medications - Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption - AST or ALT > 2 x normal range - Total bilirubin > 2.0 mg/dl - CK > 2 x normal range - eGFR < 60 mL/min/1.73m2 - Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study - Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study - Subject who treated with any investigational drugs within 90 days before the administration of investigational drug - Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days - Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin - Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days - History of drug abuse - Genetic neuromuscular disorder or family history of neuromuscular disorder - Unusual diet affected the absorption, distribution, metabolism, excretion of medications - Subjects deemed ineligible by investigator based on other reasons |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Inha Univ. Hospital | Incheon |
Lead Sponsor | Collaborator |
---|---|
Ahn-Gook Pharmaceuticals Co.,Ltd |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax (Candesartan cilexetil) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours | No | |
Primary | Cmax (Atorvastatin) | 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours | No | |
Primary | AUClast (Candesartan cilexetil) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours | No | |
Primary | AUClast (Atorvastatin) | 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours | No |
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