NCT02089399

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2014

Shorter than P25 for phase_1 healthy

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

First Submitted

Initial submission to the registry

March 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

March 14, 2014

Last Update Submit

April 27, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCtau

    Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

  • Css,max

    Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

Secondary Outcomes (2)

  • Tss,max

    Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

  • Css,min

    Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

Study Arms (2)

Treatment AB

EXPERIMENTAL

S-\>S+C

Drug: Sevikar(amlodipne/olmesartan)Drug: crestor(Rosuvastatin)

Treatment C

EXPERIMENTAL

C

Drug: crestor(Rosuvastatin)

Interventions

Sevikar(amlodipne/olmesartan)DRUG

Treatment AB

Treatment AB
crestor(Rosuvastatin)DRUG

Treatment AB/Treatment C

Treatment ABTreatment C

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects aged 19 - 55 years
  • A body mass index in the range 19 - 27 kg/m2
  • Willingness to participate during the entire study period
  • Written informed consent after being fully informed about the study procedures

You may not qualify if:

  • Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
  • History of clinically significant drug hypersensitivity
  • Use of medication within 7 days before the first dose
  • Heavy drinker (\>140 g/week)
  • Whole blood donation during 60 days before the study
  • Judged not eligible for study participation by investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, South Korea

Location

MeSH Terms

Interventions

olmesartanRosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

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

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 17, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

KR(1)