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CompletedNCT02205151Updated Oct 15, 2014

To Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets

A Phase 1 interventional study of Fimasartan and Amlodipine 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 2014-10-15.

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

Phase
Phase 1
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Male
01

Study summary

An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers

Read the detailed description

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

As period I, subjects of A Group take fimasartan and amlodipine at 1st day and subjects of B Group take fimasartan/amlodipine combination at 1st day.

And then, after wash out for 14 days, as period II, subjects of A Group take fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and amlodipine at 15th day.

At each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).

At each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).

02

Conditions studied

  • Hypertension

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Keywords

  • Fimasartan
03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 86 is close to the median of 90 across 4,994 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 of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
  3. Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent

Exclusion criteria

Exclusion Criteria:

  1. 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)
  2. History of clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.4).
  3. Subject that is judged inappropriate for participating in the study based on physical examination
  4. The levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin > 1.5 x the upper limit of normal or eGFR \< 60 mL/min/1.73m (calculated by MDRD)
  5. Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  6. systolic ≥ 140 mmHg or ≤ 100 mmHg, diastolic ≥ 90 mmHg or ≤ 65 mmHg), measured after taking a rest for 5minutes
  7. Take any other study's investigational products within 90 days prior to the first administration of study drug
  8. Donation of whole blood within 60 days prior to the first administration of study drug, or donation of any blood products within 30 days prior to the first administration of study drug
  9. Intake food like Grapefruit juice (*e.g., Grapefruit juice ≥ 1L /day) within 7 days prior to administration of study drug
  10. Use of any prescribed drugs or herbal remedies within 14 days, or use of any over-the-counter medication or vitamins within 7 days prior to the first administration of study drug
  11. Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
  12. Subject that is judged inappropriate for participating in the study by an investigator, based any other reason
05

Study design

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

Study arms

  • Other
    Treatment AB

    Treatment A (1 day) → wash-out(14days) → Treatment B (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination

    Drug: Fimasartan · Drug: Amlodipine · Drug: Fimasartan/Amlodipine combination

  • Other
    Treatment BA

    Treatment B (1 day) → wash-out(14days) → Treatment A (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination

    Drug: Fimasartan · Drug: Amlodipine · Drug: Fimasartan/Amlodipine combination

Interventions

  • DrugFimasartan
  • DrugAmlodipine
  • DrugFimasartan/Amlodipine combination
06

What researchers measure

Primary outcomes

  1. (Cmax)

    Time frame: 0~144 hour after medication

  2. (AUClast)

    Time frame: 0~144 hour after medication

Secondary outcomes

  1. (AUCinf)

    Time frame: 0~144 hour after medication

  2. (tmax)

    Time frame: 0~144 hour after medication

  3. (t1/2)

    Time frame: 0~144 hour after medication

07

Study locations

1 site
  • The Catholic university St. Mary hospital
    Seoul, 137-701, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02205151
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Kyunghee university hospital A Drug Analytical Laboratory
Responsible party
Sponsor
First posted
Jul 31, 2014
Start date
Jul 2014
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Oct 15, 2014

Study contacts

seunghoon han, M.D., Ph.D.
principal investigator · The Catholic university St. Mary hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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