Status:
UNKNOWN
Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy
Eligibility:
MALE
20-55 years
Phase:
PHASE1
Brief Summary
This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01845272
Start Date
April 1 2013
End Date
August 1 2013
Last Update
May 3 2013
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