to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers (NVP-1205)

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ezetrol; Drug: Crestor+Ezetrol; Drug: Crestor

Study type: Interventional

Funder types: Industry

Identifiers

NCT02289430

NVP-1205-02

Details and patient eligibility

About

The purpose of this study is to compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe.

Full description

drug interaction : rosuvastatin, ezetimibe

Enrollment: 59 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects age between 19 and 45 singed informed consent

Exclusion criteria

• Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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59 participants in 3 patient groups

Crestor+Ezetrol

Experimental group

Description:

rosuvastatin+ezetimibe

Treatment:

Drug: Crestor+Ezetrol

Ezetrol

Active Comparator group

Description:

ezetimibe

Treatment:

Drug: Ezetrol

Crestor

Active Comparator group

Description:

rosuvastatin

Treatment:

Drug: Crestor