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Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan

NCT01609907 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-06-01

No results posted yet for this study

Summary

The objective of this study is to compare pharmacokinetics after single oral administration of rosuvastatin and valsartan each separately versus coadministration of rosuvastatin and valsartan in healthy male volunteers.

Conditions

Interventions

DRUG

Rosuvastatin+Valsartan (Sequence 1)

Period 1(A) Period 2(B) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)

DRUG

Rosuvastatin+Valsartan (Sequence 2)

Period 1(C) Period 2(A) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)

DRUG

Rosuvastatin+Valsartan (Sequence 3)

Period 1(B) Period 2(C) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)

DRUG

Rosuvastatin+Valsartan (Sequence 4)

Period 1(C) Period 2(B) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)

DRUG

Rosuvastatin+Valsartan (Sequence 5)

Period 1(B) Period 2(A) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)

DRUG

Rosuvastatin+Valsartan (Sequence 6)

Period 1(A) Period 2(C) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • Woo-Seung Huh, MD, PhD. · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT01609907 on ClinicalTrials.gov