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 combination drug, Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02995720

BR-FARC-CT-103

Details and patient eligibility

About

An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.

Enrollment: 60 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

---

60 participants in 2 patient groups

1

Experimental group

Description:

A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin

Treatment:

Drug: Fimasartan/Amlodipine combination drug, Rosuvastatin

2

Active Comparator group

Description:

Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin

Treatment:

Drug: Fimasartan/Amlodipine combination drug, Rosuvastatin