Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate

Phase 1

• Conditions: Healthy
• Interventions: Drug: candesartan cilexetil 32mg, amlodipine 10mg

• Registration Number: NCT01845272
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-30
• Last Update Submitted: 2013-04-30
• Study First Posted: 2013-05-03
• Last Update Posted: 2013-05-03
• Primary Completion: 2013-07
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 1	candesartan cilexetil 32mg, amlodipine 10mg	single administration : candesartan cilexetil 32mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral).
Part 2	candesartan cilexetil 32mg, amlodipine 10mg	single administration : amlodipine 10mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral).

Primary Outcome Measures

Name	Time	Method
Assessment of the drug-drug interactions of candesartan and amlodipine	10 days