Investigating the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Rosuvastatin 20mg; Drug: Ezetimibe 10mg; Drug: Rosuvastatin 20mg + Ezetimibe 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02127320

HM-ROZE-101

Details and patient eligibility

About

The purpose of this study is to investigate the pharmacokinetic drug interactions between Rosuvastatin and Ezetimibe in Healthy Male Subjects

Enrollment: 24 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteer, age 19~45 years
• The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
• Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

Exclusion criteria

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
• History of relevant drug allergies or clinically significant hypersensitivity reaction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Rosuvastatin 20mg → Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg

Treatment:

Drug: Rosuvastatin 20mg

Drug: Rosuvastatin 20mg + Ezetimibe 10mg

Drug: Ezetimibe 10mg

Sequence 2

Experimental group

Description:

Rosuvastatin 20mg and Ezetimibe 10mg→ Rosuvastatin 20mg → Ezetimibe 10mg

Treatment:

Drug: Rosuvastatin 20mg

Drug: Rosuvastatin 20mg + Ezetimibe 10mg

Drug: Ezetimibe 10mg

Sequence 3

Experimental group

Description:

Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg → Rosuvastatin 20mg

Treatment:

Drug: Rosuvastatin 20mg

Drug: Rosuvastatin 20mg + Ezetimibe 10mg

Drug: Ezetimibe 10mg

Sequence 4

Experimental group

Description:

Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg → Rosuvastatin 20mg

Treatment:

Drug: Rosuvastatin 20mg

Drug: Rosuvastatin 20mg + Ezetimibe 10mg

Drug: Ezetimibe 10mg

Sequence 5

Experimental group

Description:

Ezetimibe 10mg → Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg

Treatment:

Drug: Rosuvastatin 20mg

Drug: Rosuvastatin 20mg + Ezetimibe 10mg

Drug: Ezetimibe 10mg

Sequence 6

Experimental group

Description:

Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg

Treatment:

Drug: Rosuvastatin 20mg

Drug: Rosuvastatin 20mg + Ezetimibe 10mg

Drug: Ezetimibe 10mg