Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg

HanAll Biopharma

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Amlodipine10mg; Drug: Candesartan32mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01806311

HAMCAO12I_1

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

PartA: Candesartan, Candesartan + Amolodipine

Active Comparator group

Description:

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

Treatment:

Drug: Candesartan32mg

Drug: Amlodipine10mg

PartB: Amlodipine, Amlodipine+Candesartan

Active Comparator group

Description:

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

Treatment:

Drug: Candesartan32mg

Drug: Amlodipine10mg