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Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg

NCT ID: NCT01806311

Last Updated: 2025-04-20

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-08-31

Brief Summary

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Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg in healthy male volunteers.

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Detailed Description

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Conditions

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Hypertension

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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PartA: Candesartan, Candesartan + Amolodipine

Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally

Group Type ACTIVE_COMPARATOR

Candesartan32mg

Intervention Type DRUG

Amlodipine10mg

Intervention Type DRUG

PartB: Amlodipine, Amlodipine+Candesartan

Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally

Group Type ACTIVE_COMPARATOR

Candesartan32mg

Intervention Type DRUG

Amlodipine10mg

Intervention Type DRUG

Interventions

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Candesartan32mg

Intervention Type DRUG

Amlodipine10mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male, Age 20 to 45
2. Subject must be willing and able to provide written informed consent to the study.

Exclusion Criteria

1. History of any significant sickness, liver system, gall bladder system, kidney, nerve system, respiratory system, blood tumor, endocrine system, urinary system, mental disease, muscloskeletal system, immunity system, the ear, nose and throat system and cardiovascular system.
2. History of any significant gastrointestinal system and surgery of gastrointestinal.
3. History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic.
4. Over 10 tobaccos a day.
5. Other condition which in the opinion of the investigator preclude endrollment into the study.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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HanAll BioPharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jang Hee Hong, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Chungnam national university hospital, Clinical trial center

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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HAMCAO12I_1

Identifier Type: -

Identifier Source: org_study_id

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