Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate

Healthy Clinical Trial

— CCA  

Official title:

Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01845272
• Other study ID #: CJ_CCA_101
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 23, 2013
• Last updated: April 30, 2013
• Start date: April 2013
• Est. completion date: August 2013

Study information

• Verified date: April 2013
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• candesartan cilexetil 32mg, amlodipine 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
Treatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the drug-drug interactions of candesartan and amlodipine		10 days	No