NCT02995720

Brief Summary

An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2016

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

August 26, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 1, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

December 1, 2016

Last Update Submit

August 9, 2017

Conditions

Hypertension, Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

  • Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin

    0~72 hour after medication

  • AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin

    0~72 hour after medication

Study Arms (2)

1

EXPERIMENTAL

A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin

Drug: Fimasartan/Amlodipine combination drug, Rosuvastatin

2

ACTIVE COMPARATOR

Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin

Drug: Fimasartan/Amlodipine combination drug, Rosuvastatin

Interventions

Fimasartan/Amlodipine combination drug, RosuvastatinDRUG
12

Eligibility Criteria

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

You may qualify if:

  • 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

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

fimasartanRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

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

December 1, 2016

First Posted

December 16, 2016

Study Start

August 26, 2016

Primary Completion

November 10, 2016

Study Completion

May 30, 2017

Last Updated

August 10, 2017

Record last verified: 2017-08