NCT03009474

Brief Summary

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 hypertension

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_1 hypertension

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

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

March 11, 2015

Last Update Submit

January 3, 2017

Conditions

HypertensionHyperlipidemias

Outcome Measures

Primary Outcomes (1)

  • Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin

    Up to 144 hours post-dose

Secondary Outcomes (5)

  • Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin

    Up to 144 hours post-dose

  • Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin

    Up to 144 hours post-dose

  • Half life (t1/2) of amlodipine, valsartan, rosuvastatin

    Up to 144 hours post-dose

  • Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin

    Up to 144 hours post-dose

  • Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin

    Up to 144 hours post-dose

Study Arms (2)

CJ-30060

EXPERIMENTAL

Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg

Drug: Exforge tab 5/160mg, Crestor tab 10mg

Exforge tab 5/160mg, Crestor tab 10mg

ACTIVE COMPARATOR

Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg

Drug: CJ-30060

Interventions

CJ-30060DRUG

Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg

Exforge tab 5/160mg, Crestor tab 10mg
Exforge tab 5/160mg, Crestor tab 10mgDRUG

Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg

CJ-30060

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male aged 20 to 45 years at the screening
  • Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive)
  • Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.

You may not qualify if:

  • Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease.
  • Subject who have symptoms, result from acute disease within 28days before first administration.
  • Subject who have chronic persisting disease with clinical significance.
  • Subject who fall under the criteria below in laboratory test.
  • AST/ALT \> UNL (upper normal limit) x 2
  • Total bilirubin \> UNL x 1.5
  • In case of renal failure that creatine clearance is less than 50mL/min according to Cockcroft-Gault
  • CPK \> UNL x 2.5
  • Subject who with low blood pressure with clinical significance at screening test.
  • (systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60 mmHg)
  • Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

Amlodipine, Valsartan Drug CombinationRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ValsartanTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmlodipineDihydropyridinesPyridinesValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDrug CombinationsPharmaceutical PreparationsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Study Officials

  • Ji Young Park, PhD

    Korea University Anam Hospital

    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

March 11, 2015

First Posted

January 4, 2017

Study Start

February 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 4, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)