Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects

Ahn-Gook Pharmaceuticals

Status and phase

Unknown

Phase 1

Conditions

Healthy Male Subjects

Treatments

Drug: Candesartan cilexetil

Study type

Interventional

Funder types

Industry

Identifiers

NCT02609711

AGCA_DI_1501

Details and patient eligibility

About

primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and Atorvastatin

Enrollment

90 estimated patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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