Overview

This trial is active, not recruiting.

Condition healthy
Treatments candesartan cilexetil 32mg, amlodipine 10mg
Phase phase 1
Sponsor CJ HealthCare Corporation
Start date April 2013
End date July 2013
Trial size 40 participants
Trial identifier NCT01845272, CJ_CCA_101

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
single administration : candesartan cilexetil 32mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral).
candesartan cilexetil 32mg, amlodipine 10mg atacand 32mg, norvasc 10mg
Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
candesartan cilexetil 32mg, amlodipine 10mg atacand 32mg, norvasc 10mg
Treatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
(Experimental)
single administration : amlodipine 10mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral).
candesartan cilexetil 32mg, amlodipine 10mg atacand 32mg, norvasc 10mg
Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
candesartan cilexetil 32mg, amlodipine 10mg atacand 32mg, norvasc 10mg
Treatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover

Primary Outcomes

Measure
Assessment of the drug-drug interactions of candesartan and amlodipine
time frame: 10 days

Eligibility Criteria

Male participants from 20 years up to 55 years old.

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

Additional Information

Official title Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers.
Principal investigator Jae-wook Ko, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by CJ HealthCare Corporation.