NCT03657472

Brief Summary

To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 hypertension

Timeline
Completed

Started Sep 2016

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

September 19, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2016

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

1 month

First QC Date

August 9, 2018

Last Update Submit

September 2, 2018

Conditions

HypertensionHyperlipidemia

Outcome Measures

Primary Outcomes (6)

  • Cmax of amlodipine

    Up to 72 hours

  • Cmax of valsartan

    Up to 72 hours

  • Cmax of atorvastatin

    Up to 72 hours

  • AUCt of amlodipine

    Up to 72 hours

  • AUCt of valsartan

    Up to 72 hours

  • AUCt of atorvastatin

    Up to 72 hours

Secondary Outcomes (14)

  • tmax of amlodipine

    Up to 72 hours

  • tmax of valsartan

    Up to 72 hours

  • tmax of atorvastatin

    Up to 72 hours

  • t1/2 of atorvastatin

    Up to 72 hours

  • t1/2 of amlodipine

    Up to 72 hours

  • +9 more secondary outcomes

Study Arms (3)

Sequence 1(RTR)

EXPERIMENTAL
Drug: CJ-30061Drug: Exforge® 5/160mg & Lipitor® 20mg

Sequence 2(RRT)

EXPERIMENTAL
Drug: CJ-30061Drug: Exforge® 5/160mg & Lipitor® 20mg

Sequence 3(TRR)

EXPERIMENTAL
Drug: CJ-30061Drug: Exforge® 5/160mg & Lipitor® 20mg

Interventions

CJ-30061DRUG

Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)

Sequence 1(RTR)Sequence 2(RRT)Sequence 3(TRR)
Exforge® 5/160mg & Lipitor® 20mgDRUG

Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg

Sequence 1(RTR)Sequence 2(RRT)Sequence 3(TRR)

Eligibility Criteria

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

You may qualify if:

  • Healthy male aged 19 to 55 years at the time of signing informed consent form.
  • Subject with BMI from 19kg/m\^2 to 27kg/m\^2
  • Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study

You may not qualify if:

  • Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease.
  • Subject who fall under the criteria below in laboratory test.
  • AST/ALT, total bilirubin, GGT, Uric acid \> UNL (upper normal limit) x 1.5
  • CPK \> UNL x 2.5
  • CrCL \< 60mL/min
  • Subject who fall under the criteria below in Blood Pressure test (siSBP \< 100mmHg/siSBP ≥ 150mmHg or siDBP \< 70mmHg/siDBP ≥ 100mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

Amlodipine, Valsartan Drug CombinationAtorvastatin

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 PreparationsPyrrolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • JaeWook Ko, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 9, 2018

First Posted

September 5, 2018

Study Start

September 19, 2016

Primary Completion

October 29, 2016

Study Completion

November 9, 2016

Last Updated

September 5, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)