NCT01609907

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
Last Updated

June 1, 2012

Status Verified

January 1, 2012

Enrollment Period

6 months

First QC Date

January 5, 2012

Last Update Submit

May 31, 2012

Conditions

HypertensionHyperlipidemia

Keywords

Drug interactionYH14700RosuvastatinValsartanYuhan

Outcome Measures

Primary Outcomes (5)

  • Cmax,ss of valsartan

    18 points up to Day 4

  • AUCt,ss of valsartan

    18 points up to Day 4

  • Cmax,ss of rosuvastatin

    18 points up to Day 4

  • AUCt,ss of rosuvastatin

    18 points up to Day 4

  • t1/2 of rosuvastatin

    18 points up to Day 4

Secondary Outcomes (8)

  • Tmax,ss of valsartan

    18 points up to Day 4

  • t1/2 of valsartan

    18 points up to Day 4

  • Cmin,ss of valsartan

    18 points up to Day 4

  • Tmax,ss of rosuvastatin

    18 points up to Day 4

  • Cmin,ss of rosuvastatin

    18 points up to Day 4

  • +3 more secondary outcomes

Study Arms (6)

Sequence 1

EXPERIMENTAL
Drug: Rosuvastatin+Valsartan (Sequence 1)

Sequence 2

EXPERIMENTAL
Drug: Rosuvastatin+Valsartan (Sequence 2)

Sequence 3

EXPERIMENTAL
Drug: Rosuvastatin+Valsartan (Sequence 3)

Sequence 4

EXPERIMENTAL
Drug: Rosuvastatin+Valsartan (Sequence 4)

Sequence 5

EXPERIMENTAL
Drug: Rosuvastatin+Valsartan (Sequence 5)

Sequence 6

EXPERIMENTAL
Drug: Rosuvastatin+Valsartan (Sequence 6)

Interventions

Rosuvastatin+Valsartan (Sequence 1)DRUG

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)

Sequence 1
Rosuvastatin+Valsartan (Sequence 2)DRUG

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)

Sequence 2
Rosuvastatin+Valsartan (Sequence 3)DRUG

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)

Sequence 3
Rosuvastatin+Valsartan (Sequence 4)DRUG

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)

Sequence 4
Rosuvastatin+Valsartan (Sequence 5)DRUG

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)

Sequence 5
Rosuvastatin+Valsartan (Sequence 6)DRUG

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)

Sequence 6

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers of aged between 20 years to 50 years
  • Have a body mass index (BMI) between 19kg/m2 and 27kg/m2 inclusive
  • Eligible subjects with acceptable medical history, physical examination laboratory tests, ECG during screening period
  • Able to follow instruction and can participate in whole procedure of the trial
  • Have signed a written informed consent voluntary, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the drug
  • Anticipate having the same adult female sexual partner, who have no possibility of being pregnant or breast-feeding and take steps to prevent conception during the study

You may not qualify if:

  • Have history of cardiovascular disorder(congestive heart failure, complications of coronary artery stenosis stroke and etc.), respiratory disorder, renal disorder(severe renal failure and etc.), liver disorder(moderate or severe liver failure and etc.) endocrine system disorder(diabetics, impaired glucose tolerance and etc.), digestive system disorder, central nervous system disorder, mental illness or malignant tumor
  • Have history of gastrointestinal disease(Crohn's disease, ulcer and etc.), gastrointestinal surgery(simple appendectomy or herniotomy excluded) that can affect the absorption of the drug
  • Have suffered from a clinically significant disease within 30 days prior to the first administration
  • Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with rosuvastatin or valsartan, or other drug(aspirin, antibiotics and etc.)
  • Have genetic myopathy, family history of myopathy, or history of myopathy to drugs
  • Have systolic blood pressure higher than 150mmHg or lower than 90mmHg, or diastolic blood pressure higher than 100mmHg or lower than 60mmHg, or pulse rate more than 100times/min or less than 40times/min
  • Have history of drug abuse or shown positive on drug abuse during drug screening test
  • Participated in any other clinical trials within 90 days prior to the first administration
  • Have used any herbal medicine, prescription drug, or generic medicine within 30 days, 14 days or 7 days prior to the first administration, respectively (provided, however, if other conditions are judged to be eligible by investigators, subjects can participate in the trial)
  • Donated whole blood or blood component within 60 days or 30 days prior to the first administration, respectively, or received transfusion within 30 days prior to the first administration
  • Excessive alcohol drinker(\> 140g/week; 1 glass of 12° wine(125mL) = 12.0g, 1 glass of 4° beer(250mL) = 8g, 0.5 bottle of soju(180mL) = 28.8g)
  • Heavy smoker(\> 20 cigarettes/day)
  • Excessive caffeine drinker(\> 4 cups/day)
  • Shown positive on serum test(HBsAg, HCV Ab, HIV Ab tests)
  • Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons including their abnormal values in clinical laboratory test
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuhan Corporation

Seoul, South Korea

Location

MeSH Terms

Conditions

HypertensionHyperlipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Woo-Seung Huh, MD, PhD.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2012

First Posted

June 1, 2012

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 1, 2012

Record last verified: 2012-01

Locations

KR(1)