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to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers

A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02289430
Acronym
NVP-1205
Enrollment
59
Registered
2014-11-13
Start date
2014-12-31
Completion date
2015-02-28
Last updated
2016-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed description

drug interaction : rosuvastatin, ezetimibe

Interventions

DRUGCrestor+Ezetrol

rosuvastatin+ezetimibe

DRUGEzetrol

ezetimibe

rosuvastatin

Sponsors

NVP Healthcare
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Area Under Curve0-24h

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026