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NCT02566187 Clinical Trial

A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02566187
Other study ID # BR-FAVC-CT-101
Secondary ID
Status Completed
Phase Phase 1
First received September 30, 2015
Last updated February 23, 2016
Start date August 2015
Est. completion date October 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 phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date October 2015
Est. primary completion date October 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/Atorvastatin Combination Tablet

• Fimasartan

• Atorvastatin

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 Maximum observed concentration(Cmax) of Fimasartan and Atorvastatin 0~48 hour after medication Yes
Primary Area under the curve(AUCt) of Fimasartan and Atorvastatin 0~48 hour after medication Yes
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