Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate (CCA)

HK inno.N

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: candesartan cilexetil 32mg, amlodipine 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01845272

CJ_CCA_101

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Part 1

Experimental group

Description:

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

Treatment:

Drug: candesartan cilexetil 32mg, amlodipine 10mg

Drug: candesartan cilexetil 32mg, amlodipine 10mg

Part 2

Experimental group

Description:

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

Treatment:

Drug: candesartan cilexetil 32mg, amlodipine 10mg

Drug: candesartan cilexetil 32mg, amlodipine 10mg