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

NCT02205190 | Completed Phase 1 DMC

• 1 other identifier: BR-FRC-CT-101
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypertension

Keywords

Fimasartan

Outcome Measures

Primary Outcomes (2)

• (AUClast)

  0~72 hour after medication

• (Cmax)

  0~72 hour after medication

Secondary Outcomes (3)

• (AUCinf)

  0~72 hour after medication

• (tmax)

  0~72 hour after medication

• (t1/2)

  0~72 hour after medication

Study Arms (2)

Treatment AB

OTHER

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

Treatment BA

OTHER

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

Fimasartan DRUG

Treatment AB; Treatment BA

Rosuvastatin DRUG

Treatment AB; Treatment BA

Fimasartan/Rosuvastatin combination DRUG

Treatment AB; Treatment BA

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subject, aged 19- 55 years at screening.
• Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} \* 0.9
• No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease that requires treatment
• 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
• 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

You may not qualify if:

• History of clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.5).
• 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)
• Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening
• Active liver disease, or the levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin \> 1.5 x the upper limit of normal
• Creatinine clearance \< 60 mL/min (calculated by Cockcroft-Gault formula using serum creatinine)
• Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• 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)
• 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
• 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)
• 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
• 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)
• 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
• 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)
• Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Kyungpook National University Hospital: collaborator

Study Sites (1)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• youngran yoon, M.D., Ph.D.

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 31, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-07

Locations

KR (1)