Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate

NCT01845272 | Unknown Phase 1

• 1 other identifier: CJ_CCA_101
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Assessment of the drug-drug interactions of candesartan and amlodipine

  10 days

Study Arms (2)

Part 1

EXPERIMENTAL

single administration : candesartan cilexetil 32mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral).

Drug: candesartan cilexetil 32mg, amlodipine 10mg

Part 2

EXPERIMENTAL

single administration : amlodipine 10mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral).

Drug: candesartan cilexetil 32mg, amlodipine 10mg

Interventions

candesartan cilexetil 32mg, amlodipine 10mg DRUG

Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover

Also known as: atacand 32mg, norvasc 10mg

Part 1; Part 2

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

MeSH Terms

Interventions

candesartan cilexetil; Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jae-wook Ko, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 3, 2013

Record last verified: 2013-04