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

Boryung

Status and phase: Completed; Phase 1

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: Atorvastatin; Drug: Fimasartan; Drug: Fimasartan/Atorvastatin Combination Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02566187

BR-FAVC-CT-101

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Group 1

Other group

Description:

Subjects of Group 1 take Fimasartan and Atorvastatin Individual Tablets at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 1 take a Fimasartan/Atorvastatin Combination Tablet at 8th day.

Treatment:

Drug: Atorvastatin

Drug: Fimasartan

Drug: Fimasartan/Atorvastatin Combination Tablet

Group 2

Other group

Description:

Subjects of Group 2 take a Fimasartan/Atorvastatin Combination Tablet at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 2 take Fimasartan and Atorvastatin Individual Tablets at 8th day.

Treatment:

Drug: Atorvastatin

Drug: Fimasartan

Drug: Fimasartan/Atorvastatin Combination Tablet