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Completed

NCT Number: NCT01926652

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

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.

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Key information

Conditions

Age range

20 year–55 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

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

Exclusion criteria

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

Treatment and study plan

candesartan cilexetil 32mg, amlodipine 10mg

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.

Other names: atacand 32mg, norvasc 10mg

Primary outcomes

  1. AUC, Cmax

    Time frame: 7days, 10days

Secondary outcomes

  1. Cmin, tmax, CL/F

    Time frame: 7days, 10days

Sponsors and collaborators

Lead sponsor

Shin Poong Pharmaceutical Co. Ltd.

Industry

Registry information

Official study title

An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Amlodipine 10mg and Candesartan 32mg in Healthy Male Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 21, 2013
Registry last updated
Aug 21, 2013

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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