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Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers

NCT01918709 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-08-08

No results posted yet for this study

Summary

Primary objective : To investigate pharmacokinetics after concomitant administration of valsartan and rosuvastatin compared to single administration of valsartan or rosuvastatin in healthy male volunteers

Secondary objective : To investigate safety profiles after the administration of valsartan or rosuvastatin alone and concomitant administration of valsartan and rosuvastatin in healthy male volunteers

Conditions

  • Hypertension, Hyperlipidemia

Interventions

DRUG

Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

DRUG

Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

DRUG

Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

DRUG

Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

DRUG

Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

DRUG

Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sponsors & Collaborators

  • LG Life Sciences

    lead INDUSTRY

Principal Investigators

  • Jae-Wook Ko, Professor · Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01918709 on ClinicalTrials.gov