NCT02814500

Brief Summary

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_1 healthy

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

First Submitted

Initial submission to the registry

June 12, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

June 12, 2016

Last Update Submit

June 23, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUClast

    0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr

  • Cmax

    0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr

Study Arms (2)

A group

EXPERIMENTAL

Amlodipine and Rosuvastatin, DP-R212

Drug: DP-R212Drug: AmlodipineDrug: Rosuvastatin

B group

EXPERIMENTAL

DP-R212, Amlodipine and Rosuvastatin

Drug: DP-R212Drug: AmlodipineDrug: Rosuvastatin

Interventions

DP-R212DRUG

Investigational product is prescribed to all of randomized subjects

A groupB group
AmlodipineDRUG

Investigational product is prescribed to all of randomized subjects

A groupB group
RosuvastatinDRUG

Investigational product is prescribed to all of randomized subjects

A groupB group

Eligibility Criteria

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

You may qualify if:

  • BMI 17.5\~30.5
  • 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 30 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

MeSH Terms

Interventions

AmlodipineRosuvastatin Calcium

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Central Study Contacts

Min-Geol Kim, M.D

CONTACT

mgkim@jbcp.kr

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

June 12, 2016

First Posted

June 27, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

June 27, 2016

Record last verified: 2016-06