Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
• Treatments: Atorvastatin; Atorvastatin Calcium; Candesartan; Candesartan cilexetil

Criteria

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