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Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate

Information source: CJ HealthCare Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: candesartan cilexetil 32mg, amlodipine 10mg (Drug); candesartan cilexetil 32mg, amlodipine 10mg (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: CJ HealthCare Corporation

Official(s) and/or principal investigator(s):
Jae-wook Ko, MD, PhD, Principal Investigator, Affiliation: Samsung Medical Center

Summary

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

Clinical Details

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

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

Primary outcome: Assessment of the drug-drug interactions of candesartan and amlodipine

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: April 2013
Last updated: April 30, 2013

Page last updated: August 23, 2015

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