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

Sponsor
Shin Poong Pharmaceutical Co. Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01926652
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
1
Duration (Months)
33.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: candesartan cilexetil 32mg, amlodipine 10mg
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: candesartan

Single administration : candesartan cilexetil 32mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd

Drug: candesartan cilexetil 32mg, amlodipine 10mg
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

    		•
    Experimental: amlodipine

    Single administration : amlodipine 10mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd

    Drug: candesartan cilexetil 32mg, amlodipine 10mg
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUC, Cmax [7days, 10days]

    Secondary Outcome Measures

    1. Cmin, tmax, CL/F [7days, 10days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Male volunteers in the age between 20 and 55 years old(inclusive).

    2. Body weight >= 55kg and Body mass index (BMI) in the range of calculated IBW ±20%.

    3. Subjects without a hereditary problems or chronic desease.

    4. Subjects whose clinical laboratory test values are inside the accepted normal range.

    5. Understand the requirements of the study and voluntarily consent to participate in the study.

    Exclusion Criteria:

    1. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines.

    2. Systolic blood pressure range ≥150 mmHg or ≤ 100 mmHg or diastolic blood pressure range ≥ 95 mmHg or ≤ 60 mmHg.

    3. Subject with symptoms of acute disease within 14days prior to study medication dosing.

    4. Subjects with a history of clinically significant allergies of amlodipin or candesartan or CCB or other medicine (ex. aspirin or antibiotics).

    5. Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

    6. Serum creatinine > 1.2mg/dL.

    7. smoking > 10 cigarettes/day.

    8. alcohol > 210g/week.

    9. Positive test results for drug test in urin or subject with history of substance abuse.

    10. Participation in any clinical investigation within 2 months prior to study medication dosing.

    11. 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.

    12. Subjects considered as unsuitable based on medical judgement by investigators.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chungnam national university hospital, clinical trial center Daejeon Chungcheongbul-do Korea, Republic of 301-721

    Sponsors and Collaborators

    • Shin Poong Pharmaceutical Co. Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shin Poong Pharmaceutical Co. Ltd.
    ClinicalTrials.gov Identifier:
    NCT01926652
    Other Study ID Numbers:
    • SP-AC-001
    First Posted:
    Aug 21, 2013
    Last Update Posted:
    Aug 21, 2013
    Last Verified:
    Aug 1, 2013
    Additional relevant MeSH terms:
    Amlodipine
    Candesartan
    Candesartan cilexetil

    Study Results

    No Results Posted as of Aug 21, 2013