Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects

An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects

An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety after multiple oral doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.

Study Overview

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

Detailed Description

After subjects have signed informed consent voluntarily, they go through screening period for within 28 days.

As period I, subjects of Cohort1 take fimasartan and Amlodipine for 10 days and subjects of Cohort2 take rosuvastatin for 6 days.

And then, as period II, subjects of both Cohorts take fimasartan, Amlodipine and rosuvastatin in Cohort1 case for 6 days and in Cohort2 case for 10 10days.

For Fimasartan, subjects of Cohort1 have blood sampling 8th, 9th, 14th, 15th day before medication, 10th and 16th day before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24hour after medication(32 times in total).

For Amlodipine, subjects of Cohort1 have blood sampling 8th, 9th, 14th, 15th day before medication, 10th and 16th day before and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 24hour after medication(30 times in total).

For Rosuvastatin and N-desmethyl rosuvastatin, subjects of Cohort2 have blood sampling 4th, 5th, 14th, 15th day before medication, 6th and 16th day before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24hour after medication(28 times in total).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, Korea, Republic of
    • Inje University Busan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Healthy male subject, aged 19- 50 years at screening.
2. Body weight within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9

Exclusion Criteria:

1. 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)
2. Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening
3. Active liver disease, or the levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin > 1.25 x the upper limit of normal
4. 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)]
5. 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)

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: Cohort1; Treatment AB → ABC Treatment A+B (10days) → Treatment A+B+C (6days) Treatment A: Fimasartan Treatment B: Amlodipine Treatment C: Rosuvastatin	Drug: Rosuvastatin; Drug: Amlodipine; Drug: Fimasartan
Other: Cohort2; Treatment C → ABC Treatment C (6days) → Treatment A+B+C (10days) Treatment A: Fimasartan Treatment B: Amlodipine Treatment C: Rosuvastatin	Drug: Rosuvastatin; Drug: Amlodipine; Drug: Fimasartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,ss	When 1 cohort, it's a measure on Fimasartan and Amlodipine. and when another cohort, it's a measure on Rosuvastatin	Time Frame: 0~24 hour after medication
AUC tau,ss	When 1 cohort, it's a measure on Fimasartan and Amlodipine. and when another cohort, it's a measure on Rosuvastatin	Time Frame: 0~24 hour after medication

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Inje University

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 21, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Fimasartan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine; Rosuvastatin Calcium
• Other Study ID Numbers: BR-FARC-CT-101