NCT02789475

Brief Summary

An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started May 2016

Shorter than P25 for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

May 23, 2016

Last Update Submit

June 2, 2016

Conditions

HypertensionHyperlipidemias

Outcome Measures

Primary Outcomes (2)

  • AUCτ,ss of Amlodipine and Rosuvastatin

    0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr

  • Cmax,ss of Amlodipine and Rosuvastatin

    0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr

Study Arms (2)

amplodipine group

EXPERIMENTAL

Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days

Drug: AmlodipineDrug: Rosuvastatin

rosuvastatin group

EXPERIMENTAL

Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days

Drug: AmlodipineDrug: Rosuvastatin

Interventions

AmlodipineDRUG

Amlodipine administration

amplodipine grouprosuvastatin group
RosuvastatinDRUG

Rosuvastatin administration

amplodipine grouprosuvastatin group

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18-29
  • signed the informed consent form prior to the study participation

You may not qualify if:

  • Clinically significant disease
  • Previously donate whole blood within 60 days or component blood within 14 days
  • Clinically significant allergic disease
  • Taken IP in other trial within 90 days
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha university hospital

Jung-gu, Incheon, 400-711, South Korea

RECRUITING

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

AmlodipineRosuvastatin 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 Officials

  • Chul woo Kim, Ph.D.

    Inha University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chul woo Kim, Ph.D.

CONTACT

82-92-890-1168cwkim1805@inha.ac.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 3, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)