Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate (CCA)

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: candesartan cilexetil 32mg, amlodipine 10mg; Drug: candesartan cilexetil 32mg, amlodipine 10mg

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; 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; Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover; Other Names: atacand 32mg, norvasc 10mg; Drug: 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; Other Names: atacand 32mg, norvasc 10mg
Experimental: Part 2; single administration : amlodipine 10mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral).	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; Other Names: atacand 32mg, norvasc 10mg; Drug: 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; Other Names: atacand 32mg, norvasc 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the drug-drug interactions of candesartan and amlodipine	10 days

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Jae-wook Ko, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: April 30, 2013
• First Posted (Estimate): May 3, 2013

Study Record Updates

• Last Update Posted (Estimate): May 3, 2013
• Last Update Submitted That Met QC Criteria: April 30, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Candesartan; Candesartan cilexetil
• Other Study ID Numbers: CJ_CCA_101