Healthy Male Subjects
Conditions
Brief summary
primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and Atorvastatin
Interventions
DRUGCandesartan cilexetil
Sponsors
Ahn-Gook Pharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax (Candesartan cilexetil) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours |
| Cmax (Atorvastatin) | 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours |
| AUClast (Candesartan cilexetil) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours |
| AUClast (Atorvastatin) | 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours |
Countries
South Korea
Outcome results
None listed