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NCT02569814 Clinical Trial

A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02569814
Other study ID # BR-FARC-CT-102
Secondary ID
Status Completed
Phase Phase 1
First received October 5, 2015
Last updated February 23, 2016
Start date September 2015
Est. completion date December 2015

Study information
Verified date February 2016
Source Boryung Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria:

- a Healthy male subject, aged 19- 50 years

Exclusion Criteria:

- History of clinically significant hypersensitivity to study drug, any other drug

- Hypotension or hypertension

- Active liver disease

- History of gastrointestinal disease

- History of excessive alcohol abuse

- Participation in any other study within 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fimasartan/Amlodipine/Rosuvastatin

• Fimasartan/Amlodipine

• Rosuvastatin

Locations
Country Name City State
Korea, Republic of Inje University Busan Paik Hospital Busan

Sponsors (1)
Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax of Fimasartan, Amlodipine and Rosuvastatin 0~144 hour after medication Yes
Primary AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin 0~144 hour after medication Yes
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