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Investigating the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe

NCT ID: NCT02127320

Last Updated: 2016-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

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

Group Type EXPERIMENTAL

Rosuvastatin 20mg

Intervention Type DRUG

Ezetimibe 10mg

Intervention Type DRUG

Rosuvastatin 20mg + Ezetimibe 10mg

Intervention Type DRUG

Sequence 2

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

Group Type EXPERIMENTAL

Rosuvastatin 20mg

Intervention Type DRUG

Ezetimibe 10mg

Intervention Type DRUG

Rosuvastatin 20mg + Ezetimibe 10mg

Intervention Type DRUG

Sequence 3

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

Group Type EXPERIMENTAL

Rosuvastatin 20mg

Intervention Type DRUG

Ezetimibe 10mg

Intervention Type DRUG

Rosuvastatin 20mg + Ezetimibe 10mg

Intervention Type DRUG

Sequence 4

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

Group Type EXPERIMENTAL

Rosuvastatin 20mg

Intervention Type DRUG

Ezetimibe 10mg

Intervention Type DRUG

Rosuvastatin 20mg + Ezetimibe 10mg

Intervention Type DRUG

Sequence 5

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

Group Type EXPERIMENTAL

Rosuvastatin 20mg

Intervention Type DRUG

Ezetimibe 10mg

Intervention Type DRUG

Rosuvastatin 20mg + Ezetimibe 10mg

Intervention Type DRUG

Sequence 6

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

Group Type EXPERIMENTAL

Rosuvastatin 20mg

Intervention Type DRUG

Ezetimibe 10mg

Intervention Type DRUG

Rosuvastatin 20mg + Ezetimibe 10mg

Intervention Type DRUG

Interventions

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Rosuvastatin 20mg

Intervention Type DRUG

Ezetimibe 10mg

Intervention Type DRUG

Rosuvastatin 20mg + Ezetimibe 10mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyeong-Seok Lim, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, Korea, Republic of, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-ROZE-101

Identifier Type: -

Identifier Source: org_study_id

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