NCT02569814

Brief Summary

A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1 hypertension

Timeline
Completed

Started Sep 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

October 5, 2015

Last Update Submit

February 23, 2016

Conditions

HypertensionHyperlipidemia

Outcome Measures

Primary Outcomes (2)

  • Cmax of Fimasartan, Amlodipine and Rosuvastatin

    0~144 hour after medication

  • AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin

    0~144 hour after medication

Study Arms (2)

Group 1

OTHER

Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.

Drug: Fimasartan/Amlodipine/RosuvastatinDrug: Fimasartan/AmlodipineDrug: Rosuvastatin

Group 2

OTHER

Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.

Drug: Fimasartan/Amlodipine/RosuvastatinDrug: Fimasartan/AmlodipineDrug: Rosuvastatin

Interventions

Fimasartan/Amlodipine/RosuvastatinDRUG
Group 1Group 2
Fimasartan/AmlodipineDRUG
Group 1Group 2
RosuvastatinDRUG
Group 1Group 2

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • a Healthy male subject, aged 19- 50 years

You may not qualify if:

  • History of clinically significant hypersensitivity to study drug, any other drug
  • Hypotension or hypertension
  • Active liver disease
  • History of gastrointestinal disease
  • History of excessive alcohol abuse
  • Participation in any other study within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Busan Paik Hospital

Busan, South Korea

Location

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

fimasartanAmlodipineRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

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

October 5, 2015

First Posted

October 7, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

KR(1)