Status:

COMPLETED

Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg

Lead Sponsor:

HanAll BioPharma Co., Ltd.

Conditions:

Hypertension

Eligibility:

MALE

20-45 years

Phase:

PHASE1

Brief Summary

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.
  • History of any significant gastrointestinal system and surgery of gastrointestinal.
  • History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic.
  • Over 10 tobaccos a day.
  • Other condition which in the opinion of the investigator preclude endrollment into the study.

Key Trial Info

Start Date :

December 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2013

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT01806311

Start Date

December 1 2012

End Date

August 1 2013

Last Update

April 20 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Chungnam national university hospital,clinical trial center

Daejeon, Chungcheongbul-do, South Korea, 301-721