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CompletedNCT01926652Updated Aug 21, 2013

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

A Phase 1 interventional study of candesartan cilexetil 32mg, amlodipine 10mg in Healthy, sponsored by Shin Poong Pharmaceutical Co. Ltd.. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-21.

Sponsored by Shin Poong Pharmaceutical Co. Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Shin Poong Pharmaceutical Co. Ltd. is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    candesartan

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

    Drug: candesartan cilexetil 32mg, amlodipine 10mg

  • Experimental
    amlodipine

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

    Drug: candesartan cilexetil 32mg, amlodipine 10mg

Interventions

  • Drugcandesartan 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.

    Also known as: atacand 32mg, norvasc 10mg

06

What researchers measure

Primary outcomes

  1. AUC, Cmax

    Time frame: 7days, 10days

Secondary outcomes

  1. Cmin, tmax, CL/F

    Time frame: 7days, 10days

07

Study locations

1 site
  • Chungnam national university hospital, clinical trial center
    Daejeon, Chungcheongbul-do 301-721, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01926652
Lead sponsor
Shin Poong Pharmaceutical Co. Ltd.
Responsible party
Sponsor
First posted
Aug 21, 2013
Start date
Jul 2013
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Aug 21, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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