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CompletedNCT02397590Updated Jul 23, 2015

Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers

A Phase 1 interventional study of Fimasartan and Atorvastatin in Hypertension, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-23.

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

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Male
01

Study summary

A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/Atorvastatin combination tablet and coadministration of fimasartan and Atorvastatin in healthy male volunteers.

Read the detailed description

After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.

Group 1 period 2 period 3 period A F A F+A B F F+A A C A F+A F D A F F+A E F+A F A F F+A A F

At each period taking Fimasartan, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).

At each period taking Atorvastatin, subjects of this Group have blood sampling 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hour after medication(12 times in each period).

At each period taking Fimasartan and Atorvastatin, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).

02

Conditions studied

  • Hypertension

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Keywords

  • Fimasartan
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 36 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse 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
19 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male subject, aged 19- 50 years at screening.
  2. Body weight between 19.0 and 28.0 of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9

Exclusion criteria

Exclusion Criteria:

  1. History of any illness that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system)
  2. Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening
  3. Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  4. History of gastrointestinal disease (i.g., Crohn's disease, active peptic ulcer) or resection operation that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)]
  5. Participation in any other study within 2 months prior to the first administration of study drug (The finish time of previous study is the day of the last administration of study drug)
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Other
    A Group

    Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days)

    Drug: Fimasartan · Drug: Atorvastatin

  • Other
    B Group

    Fimasartan (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days)

    Drug: Fimasartan · Drug: Atorvastatin

  • Other
    C Group

    Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days)

    Drug: Fimasartan · Drug: Atorvastatin

  • Other
    D Group

    Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days)

    Drug: Fimasartan · Drug: Atorvastatin

  • Other
    E Group

    Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days)

    Drug: Fimasartan · Drug: Atorvastatin

  • Other
    F Group

    Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days)

    Drug: Fimasartan · Drug: Atorvastatin

Interventions

  • DrugFimasartan
  • DrugAtorvastatin
06

What researchers measure

Primary outcomes

  1. AUC tau,ss

    Time frame: Time Frame: 0~48 hour after medication

  2. Cmax,ss

    Time frame: Time Frame: 0~48 hour after medication

07

Study locations

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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02397590
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Seoul National University Hospital
Responsible party
Sponsor
First posted
Mar 25, 2015
Start date
Mar 2015
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jul 23, 2015

Oversight

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

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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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