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Safety and Pharmacokinetics Study of Amlodipine 10mg and Candesartan 32mg

NCT ID: NCT01926652

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-08-31

Brief Summary

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Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with candesartan 32mg in healthy male volunteers.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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candesartan

Single administration : candesartan cilexetil 32mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd

Group Type EXPERIMENTAL

candesartan cilexetil 32mg, amlodipine 10mg

Intervention Type DRUG

Part A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.

Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.

amlodipine

Single administration : amlodipine 10mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd

Group Type EXPERIMENTAL

candesartan cilexetil 32mg, amlodipine 10mg

Intervention Type DRUG

Part A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.

Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.

Interventions

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candesartan cilexetil 32mg, amlodipine 10mg

Part A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.

Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.

Intervention Type DRUG

Other Intervention Names

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atacand 32mg, norvasc 10mg

Eligibility Criteria

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Inclusion Criteria

1. Male volunteers in the age between 20 and 55 years old(inclusive).
2. Body weight \>= 55kg and Body mass index (BMI) in the range of calculated IBW ±20%.
3. Subjects without a hereditary problems or chronic desease.
4. Subjects whose clinical laboratory test values are inside the accepted normal range.
5. Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria

1. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines.
2. Systolic blood pressure range ≥150 mmHg or ≤ 100 mmHg or diastolic blood pressure range ≥ 95 mmHg or ≤ 60 mmHg.
3. Subject with symptoms of acute disease within 14days prior to study medication dosing.
4. Subjects with a history of clinically significant allergies of amlodipin or candesartan or CCB or other medicine (ex. aspirin or antibiotics).
5. Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
6. Serum creatinine \> 1.2mg/dL.
7. smoking \> 10 cigarettes/day.
8. alcohol \> 210g/week.
9. Positive test results for drug test in urin or subject with history of substance abuse.
10. Participation in any clinical investigation within 2 months prior to study medication dosing.
11. Subjects with whole blood donation within 2 months, component blood donation within 1 month and blood transfusion within 1 month prior to study medication dosing.
12. Subjects considered as unsuitable based on medical judgement by investigators.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shin Poong Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chungnam national university hospital, clinical trial center

Daejeon, Chungcheongbul-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SP-AC-001

Identifier Type: -

Identifier Source: org_study_id