Investigate a Pharmacokinetic Characteristics and the Safety of AG1502 in Healthy Male Subjects
- Registration Number
- NCT02614352
- Lead Sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Brief Summary
Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and Atorvastatin 40mg in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Candesartan + Atorvastatin Atorvastatin + Candesartan - AG1502 Atorvastatin + Candesartan - AG1502 AG1502 - Candesartan + Atorvastatin AG1502 -
- Primary Outcome Measures
Name Time Method AUClast (Atorvastatin) 0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours 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
- Secondary Outcome Measures
Name Time Method