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CompletedNCT00938197Updated Oct 8, 2009

A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers

A Phase 1 interventional study of Fimasartan and Amlodipine in Essential Hypertension, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-08.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study summary

To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers

02

Conditions studied

  • Essential Hypertension

Keywords

  • Fimasartan
  • Drug interaction
03

In context

Essential Hypertension

527 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.

This study's planned enrollment of 34 is below the median of 166 across 449 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • age: 20 - 40 years
  • sex: male
  • body weight: greater than 55 kg
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • known allergy to Fimasartan and amlodipine
  • existing cardiac or hematological diseases
  • existing hepatic and renal diseases
  • existing gastrointestinal diseases
  • acute or chronic diseases which could affect drug absorption or metabolism
  • history of any serious psychological disorder
  • positive drug or alcohol screening
  • smokers of 10 or more cigarettes per day 3 month ago
  • participation in a clinical trial during the last 2 months prior to the start of the study
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Active comparator
    Part A

    Drug: Fimasartan

  • Active comparator
    Part B

    Drug: Amlodipine

Interventions

  • DrugFimasartan

    Fimasartan (1d\~7d) Amlodipine (12d\~14d) Fimasartan + Amlodipine(15d\~21d)

  • DrugAmlodipine

    Amlodipine (1d\~10d) Amlodipine (25d\~27d) Fimasartan + Amlodipine(28d\~34d)

06

What researchers measure

Primary outcomes

  1. AUCss, Cmax,ss, Tmax,ss, CLss/F

    Time frame: Part A: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day Part B: 0, 1, 3, 4, 5, 6, 7, 8, 9, 11, 13, 15, 24 hours at 10 day and 34 day

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Yi S, Kim TE, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Pharmacokinetic interaction of fimasartan, a new angiotensin II receptor antagonist, with amlodipine in healthy volunteers. J Cardiovasc Pharmacol. 2011 Jun;57(6):682-9. doi: 10.1097/FJC.0b013e31821795d0. PubMed 21394036 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00938197
Lead sponsor
Boryung Pharmaceutical Co., Ltd
First posted
Jul 13, 2009
Start date
Jun 2009
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Oct 8, 2009

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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