NCT02707224

Brief Summary

A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in comparison to each component administered alone in healthy male volunteers

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2015

Typical duration for phase_1 healthy

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

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

March 9, 2016

Last Update Submit

March 21, 2016

Conditions

Healthy

Keywords

DP-R208

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    up to 72 hours post dose

  • Area under the plasma concentration versus time curve (AUC)

    up to 72 hours post dose

Study Arms (2)

Group A

EXPERIMENTAL

combination dose of Candesartan cilexetil and Rosuvastatin and DP-R208 in order

Drug: DP-R208Drug: Candesartan cilexetilDrug: Rosuvastatin

Group B

EXPERIMENTAL

DP-R208 and combination dose of Candesartan cilexetil and Rosuvastatin in order

Drug: DP-R208Drug: Candesartan cilexetilDrug: Rosuvastatin

Interventions

DP-R208DRUG

Investigational product is prescribed to all of randomized subjects

Group AGroup B
Candesartan cilexetilDRUG

Investigational product is prescribed to all of randomized subjects

Group AGroup B
RosuvastatinDRUG

Investigational product is prescribed to all of randomized subjects

Group AGroup B

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
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 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

MeSH Terms

Interventions

candesartan cilexetilRosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Min-Gul Kim, Ph.D

    Chonbuk National University 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 9, 2016

First Posted

March 14, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 23, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share