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To Evaluate the Pharmacokinetic Interactions and Safety Between Fimasartan and Rosuvastatin

This study has been completed.
Sponsor:
Collaborator:
Kyungpook National University
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01921946
First received: August 8, 2013
Last updated: October 20, 2013
Last verified: August 2013
  Purpose

A phase Ⅰ study to evaluate the pharmacokinetic interactions and safety between fimasartan and rosuvastatin in healthy male volunteers.


Condition Intervention Phase
Hypertension
Drug: Fimasartan
Drug: Rosuvastatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase Ⅰ Study to Evaluate the Pharmacokinetic Interactions and Safety Between Fimasartan and Rosuvastatin in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • (AUC tau,ss),(Cmax,ss),(Cmin,ss), (Tmax,ss), (t1/2) [ Time Frame: 0~72 hour after medication ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: August 2013
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Part A
Fimasartan (7 days) → Fimasartan + Rosuvastatin (7 days)
Drug: Fimasartan Drug: Rosuvastatin
Part B
Rosuvastatin (7 days) → Fimasartan + Rosuvastatin (7 days)
Drug: Fimasartan Drug: Rosuvastatin

Detailed Description:

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

As period I, subjects of Part A take fimasartan for 7 days and subjects of Part B take rosuvastatin for 7 days.

And then, after wash out for 7 days, as period II, subjects of both Part A and B take fimasartan and rosuvastatin for 7 days.

At each period, subjects of Part A have blood sampling 2nd, 4th, 6th day before medication, 7th day before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48hour after medication(17 times in each period, 34 times in total).

At each period, subjects of Part B have blood sampling 2nd, 4th, 6th day before medication, 7th day before and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72hour after medication(17 times in each period, 34 times in total).

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male subject, aged 20- 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:

  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 < 80 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01921946

Locations
Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Kyungpook National University
Investigators
Principal Investigator: Young Ran Yoon, M.D., Ph.D. Kyungpook National University
  More Information

No publications provided

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01921946     History of Changes
Other Study ID Numbers: BR-FMS-CT-116
Study First Received: August 8, 2013
Last Updated: October 20, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014