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CompletedNCT02205190Updated Oct 15, 2014

to Compare the Pharmacokinetics and Safety of Fimasartan/Rosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin

A Phase 1 interventional study of Fimasartan and Rosuvastatin in Hypertension, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 55 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
81
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
Male
01

Study summary

A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/rosuvastatin combination tablet and coadministration of fimasartan and rosuvastatin 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 1 Group take fimasartan and rosuvastatin at 1st day and subjects of 2 Group take fimasartan/rosuvastatin combination at 1st day.

And then, after wash out for 7 days, as period II, subjects of 1 Group take fimasartan/rosuvastatin combination at 8th day and subjects of 2 Group take fimasartan and rosuvastatin at 8th day.

At each period, subjects of 1 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in total).

At each period, subjects of 2 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 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 81 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 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male subject, aged 19- 55 years at screening.
  2. Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
  3. No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease that requires treatment
  4. Subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis) and ECG, performed within 3 weeks prior to administration of study drug
  5. 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 clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.5).
  2. 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)
  3. Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening
  4. Active liver disease, or the levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin > 1.5 x the upper limit of normal
  5. Creatinine clearance \< 60 mL/min (calculated by Cockcroft-Gault formula using serum creatinine)
  6. Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  7. 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)
  8. History of major injury, surgical operation, or suspected symptom of acute illness (severe infection, trauma, diarrhea or vomiting) within 4 weeks prior to the first administration of study drug
  9. History of excessive alcohol abuse (>21 units/week, 1 unit=10g=12.5mL of pure alcohol), or subjects who cannot abstain from drinking for at least 3 days prior to the start of this study and throughout the study period, or excessive smoking (>10 cigarettes/day)
  10. Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of study drug, and this will affect this study or the safety of the subjects in the opinion of the investigator
  11. Participation in any other study within 3 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)
  12. Donation of whole blood within 2 months prior to the first administration of study drug, or donation of any blood products within 1 month prior to the first administration of study drug
  13. Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs (*e.g., Grapefruit juice ≥ 1L /day within 7 days prior to administration of study drug)
  14. Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
  15. Subject that is judged inappropriate for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis) or any other reason
05

Study design

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

Study arms

  • Other
    Treatment AB

    Treatment A (1 day) → wash-out(7days) → Treatment B (1 day) Treatment A : Fimasartan and Rosuvastatin Treatment B : Fimasartan/Rosuvastatin combination

    Drug: Fimasartan · Drug: Rosuvastatin · Drug: Fimasartan/Rosuvastatin combination

  • Other
    Treatment BA

    Treatment B (1 day) → wash-out(7days) → Treatment A (1 day) Treatment A : Fimasartan and Rosuvastatin Treatment B : Fimasartan/Rosuvastatin combination

    Drug: Fimasartan · Drug: Rosuvastatin · Drug: Fimasartan/Rosuvastatin combination

Interventions

  • DrugFimasartan
  • DrugRosuvastatin
  • DrugFimasartan/Rosuvastatin combination
06

What researchers measure

Primary outcomes

  1. (AUClast)

    Time frame: 0~72 hour after medication

  2. (Cmax)

    Time frame: 0~72 hour after medication

Secondary outcomes

  1. (AUCinf)

    Time frame: 0~72 hour after medication

  2. (tmax)

    Time frame: 0~72 hour after medication

  3. (t1/2)

    Time frame: 0~72 hour after medication

07

Study locations

1 site
  • Kyungpook National University Hospital
    Daegu, 700-721, 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
NCT02205190
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Kyungpook National University Hospital
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

youngran yoon, M.D., Ph.D.
principal investigator · Kyungpook National University 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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