Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers.

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

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Amlodipine; Candesartan; Candesartan cilexetil

Criteria

Inclusion Criteria:

• Male volunteers in the age between 20 and 55 years old(inclusive)

• Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)

• Available for the entire study period

• Understand the requirements of the study and voluntarily consent to participate in the study

Exclusion Criteria:

• Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines

• Systolic blood pressure outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 60 to 1000 mmHg for male subjects. when screening period

• Subject with symptoms of acute disease within 14days prior to study medication dosing

• Subjects with a history of clinically significant allergies

• Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

• Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT >1.5 times to normal range or total bilirubin > 1.5times to normal range)

• History of drug abuse

• History of caffeine, alcohol, smoking abuse

• caffeine(coffee,tea,coke) or grapefruit juice > 4cups/day

• smoking > 20 cigarettes/day

• alcohol > 140g/week

• Positive test results for HBs Ab, HCV Ab, Syphilis regain test

• Participation in any clinical investigation within 30days prior to study medication dosing

• Subjects with whole blood donation within 60days, component blood donation within 30days and blood transfusion within 30days prior to study medication dosing

• Subjects considered as unsuitable based on medical judgement by investigators