Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg

February 24, 2014 updated by: HanAll BioPharma Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Chungcheongbul-do
      • Daejeon, Chungcheongbul-do, Korea, Republic of, 301-721
        • Chungnam national university hospital,clinical trial center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PartA: Candesartan, Candesartan + Amolodipine
Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
Drug: Candesartan32mg
Drug: Amlodipine10mg
Active Comparator: PartB: Amlodipine, Amlodipine+Candesartan
Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
Drug: Candesartan32mg
Drug: Amlodipine10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A : AUC, Cmax of Candesartan
Time Frame: Over a 24-hour sampling period
Over a 24-hour sampling period
Par B : AUC, Cmax of Amlodipine
Time Frame: Over a 24-hour sampling period
Over a 24-hour sampling period

Secondary Outcome Measures

Outcome Measure
Time Frame
PartA: Cmin, tmax, CL/F of Candesartan
Time Frame: Over a 24-hour sampling period
Over a 24-hour sampling period
PartB: Cmin, tmax, CL/F of Amlodipine
Time Frame: Over a 24-hour sampling period
Over a 24-hour sampling period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HanAll BioPharma Co., Ltd.

Investigators

  • Principal Investigator: Jang Hee Hong, Associate Professor, Chungnam national university hospital, Clinical trial center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 5, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAMCAO12I_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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