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NCT Number: NCT01806311

Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chungnam national university hospital,clinical trial center

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Candesartan32mg

Drug

Amlodipine10mg

Drug

Primary outcomes

  1. Part A : AUC, Cmax of Candesartan

    Time frame: Over a 24-hour sampling period

  2. Par B : AUC, Cmax of Amlodipine

    Time frame: Over a 24-hour sampling period

Secondary outcomes

  1. PartA: Cmin, tmax, CL/F of Candesartan

    Time frame: Over a 24-hour sampling period

  2. PartB: Cmin, tmax, CL/F of Amlodipine

    Time frame: Over a 24-hour sampling period

Sponsors and collaborators

Lead sponsor

HanAll BioPharma Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Multiple-dose, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of amlodipine10mg and candesartan32mg in Healthy Male Volunteers

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 7, 2013
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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