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

NCT02397538 | Completed Phase 1

• 1 other identifier: BR-FARC-CT-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Fimasartan

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cohort1

OTHER

Treatment AB → ABC Treatment A+B (10days) → Treatment A+B+C (6days) Treatment A: Fimasartan Treatment B: Amlodipine Treatment C: Rosuvastatin

Drug: Fimasartan; Drug: Amlodipine; Drug: Rosuvastatin

Cohort2

OTHER

Treatment C → ABC Treatment C (6days) → Treatment A+B+C (10days) Treatment A: Fimasartan Treatment B: Amlodipine Treatment C: Rosuvastatin

Drug: Fimasartan; Drug: Amlodipine; Drug: Rosuvastatin

Interventions

Fimasartan DRUG

Cohort1; Cohort2

Amlodipine DRUG

Cohort1; Cohort2

Rosuvastatin DRUG

Cohort1; Cohort2

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 \> 1.25 x the upper limit of normal
• 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)\]
• 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)

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Inje University: collaborator

Study Sites (1)

Inje University Busan Paik Hospital

Busan, Korea, Republic of, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan; Amlodipine; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

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: March 16, 2015
• First Posted: March 25, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 23, 2015

Record last verified: 2015-03

Locations

KR (1)