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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Fimasartan; Drug: Fimasartan/Rosuvastatin combination

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).

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Rosuvastatin; Drug: Fimasartan; 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: Rosuvastatin; Drug: Fimasartan; Drug: Fimasartan/Rosuvastatin combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(AUClast)	0~72 hour after medication
(Cmax)	0~72 hour after medication

Secondary Outcome Measures

Outcome Measure	Time Frame
(AUCinf)	0~72 hour after medication
(tmax)	0~72 hour after medication
(t1/2)	0~72 hour after medication

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Kyungpook National University Hospital
• Investigators: Principal Investigator: youngran yoon, M.D., Ph.D., Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 13, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Fimasartan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: BR-FRC-CT-101