NCT03639493

Brief Summary

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg 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

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_1

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

April 6, 2018

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2018

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

28 days

First QC Date

August 9, 2018

Last Update Submit

August 19, 2018

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (6)

  • Cmax of amlodipine

    Up to 144 hours post-dose

  • Cmax of valsartan

    Up to 144 hours post-dose

  • Cmax of rosuvastatin

    Up to 144 hours post-dose

  • AUClast of amlodipine

    Up to 144 hours post-dose

  • AUClast of valsartan

    Up to 144 hours post-dose

  • AUClast of rosuvastatin

    Up to 144 hours post-dose

Secondary Outcomes (1)

  • AUCinf of amlodipine, valsaran, rosuvastatin

    Up to 144 hours post-dose

Study Arms (2)

Sequence 1

EXPERIMENTAL

* Period 1: receive Exforge® tab 10/160mg, Crestor® tab 20mg * Period 2: receive CJ-30060 10/160/20mg

Drug: Exforge® tab 10/160mg, Crestor® tab 20mgDrug: CJ-30060 10/160/20mg

Sequence 2

EXPERIMENTAL

* Period 1: receive CJ-30060 10/160/20mg * Period 2: receive Exforge® tab 10/160mg, Crestor® tab 20mg

Drug: Exforge® tab 10/160mg, Crestor® tab 20mgDrug: CJ-30060 10/160/20mg

Interventions

Exforge® tab 10/160mg, Crestor® tab 20mgDRUG

Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg

Sequence 1Sequence 2
CJ-30060 10/160/20mgDRUG

Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg

Sequence 1Sequence 2

Eligibility Criteria

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

You may qualify if:

  • Healthy males aged 20 to 45 years at screening
  • BMI: 18 \~ 29.9kg/m\^2
  • Body weight ≥ 50kg
  • Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding

You may not qualify if:

  • Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease
  • Subjects who have symptoms of an acute disease within 28 days before first administration
  • Subjects who have clinically significant active, chronic disease
  • Subjects who fall under the criteria below in laboratory test
  • AST/ALT \> UNL (upper normal limit) x 2
  • Total bilirubin \> UNL x 1.5
  • CrCL \< 50mL/min
  • CPK \> UNL x 2.5
  • Subjects with clinically significant low blood pressure at screening test (systolic blood pressure is less than 100 mmHg or diastolic blood pressure is less than 60 mmHg)
  • Subjects 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

Interventions

Amlodipine, Valsartan Drug CombinationRosuvastatin Calcium

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

August 9, 2018

First Posted

August 21, 2018

Study Start

April 6, 2018

Primary Completion

May 4, 2018

Study Completion

May 17, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)