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

Boryung

Status and phase: Completed; Phase 1

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: Fimasartan/Amlodipine/Rosuvastatin; Drug: Fimasartan/Amlodipine; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02569814

BR-FARC-CT-102

Details and patient eligibility

About

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.

Enrollment: 100 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)

---

100 participants in 2 patient groups

Group 1

Other group

Description:

Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.

Treatment:

Drug: Rosuvastatin

Drug: Fimasartan/Amlodipine/Rosuvastatin

Drug: Fimasartan/Amlodipine

Group 2

Other group

Description:

Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.

Treatment:

Drug: Rosuvastatin

Drug: Fimasartan/Amlodipine/Rosuvastatin

Drug: Fimasartan/Amlodipine