Healthy Male Subjects
Conditions
Brief summary
Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and Atorvastatin 40mg in healthy male subjects.
Interventions
DRUGAtorvastatin + Candesartan
DRUGAG1502
Sponsors
Ahn-Gook Pharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Inclusion criteria
* Adult healthy males 19 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 |
| AUClast (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 (Atorvastatin) | 0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours |
Contacts
Primary ContactJINHYUNG KIM
Outcome results
None listed