NCT02709187

Brief Summary

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

Trial Health

100
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2016

Shorter than P25 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

First Submitted

Initial submission to the registry

February 17, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

February 17, 2016

Last Update Submit

June 7, 2016

Conditions

Healthy

Keywords

DP-R208

Outcome Measures

Primary Outcomes (2)

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

    up to 48 hours post dose

  • Peak Plasma Concentration (Cmax)

    up to 48 hours post dose

Study Arms (2)

RT group

EXPERIMENTAL

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

Drug: DP-R208Drug: Candesartan cilexetilDrug: Rosuvastatin

TR group

EXPERIMENTAL

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

Drug: DP-R208Drug: Candesartan cilexetilDrug: Rosuvastatin

Interventions

DP-R208DRUG

Investigational product is prescribed to all of randomized subjects

RT groupTR group
Candesartan cilexetilDRUG

Investigational product is prescribed to all of randomized subjects

RT groupTR group
RosuvastatinDRUG

Investigational product is prescribed to all of randomized subjects

RT groupTR group

Eligibility Criteria

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

You may qualify if:

  • BMI 18\~30
  • 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 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

February 17, 2016

First Posted

March 15, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 8, 2016

Record last verified: 2016-06