Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate
Information source: CJ HealthCare Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: candesartan cilexetil 32mg, amlodipine 10mg (Drug); candesartan cilexetil 32mg, amlodipine 10mg (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: CJ HealthCare Corporation Official(s) and/or principal investigator(s): Jae-wook Ko, MD, PhD, Principal Investigator, Affiliation: Samsung Medical Center
Summary
This study is designated to evaluate the pharmacokinetic interactions of candesartan
cilexetil and amlodipine besylate in healthy male volunteers.
Clinical Details
Official title: Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Assessment of the drug-drug interactions of candesartan and amlodipine
Eligibility
Minimum age: 20 Years.
Maximum age: 55 Years.
Gender(s): Male.
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
Locations and Contacts
Additional Information
Starting date: April 2013
Last updated: April 30, 2013
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