NCT02079506

Brief Summary

The objective of this study is to compare pharmacokinetics after single oral administration of candesartan and rosuvastatin each separately versus coadministration of candesartan and rosuvastatin in healthy male volunteers.

Trial Health

87
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 Feb 2014

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

February 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

Same day

First QC Date

March 4, 2014

Last Update Submit

March 4, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • AUCτ,ss of candesartan

    0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h

    22 points

  • Cmax,ss of candesartan

    0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h

    22 points

  • AUCτ,ss of rosuvastatin

    0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h

    28 points

  • Cmax,ss of rosuvastatin

    0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h

    28 points

Secondary Outcomes (6)

  • tmax,ss of candesartan

    22 points

  • CLss/F of candesartan

    22 points

  • Cmin,ss of candesartan

    22 points

  • tmax,ss of rosuvastatin

    28 points

  • CLss/F of rosuvastatin

    28 points

  • +1 more secondary outcomes

Study Arms (2)

Treatment A

EXPERIMENTAL
Drug: Candesartan

Treatment B

EXPERIMENTAL
Drug: Rosuvastatin

Interventions

CandesartanDRUG
Treatment A
RosuvastatinDRUG
Treatment B

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers af aged between 20 years to 45 years
  • Have a weight above 55kg and Ideal body weight (IBW) between -20% and +20% inclusive
  • Eligible subjects with acceptable medical history and physical examination

You may not qualify if:

  • \- Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with candesartan or rosuvastatin, or other drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Jung-gu, Daejeon, 301-721, South Korea

Location

MeSH Terms

Interventions

candesartanRosuvastatin Calcium

Intervention Hierarchy (Ancestors)

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

Study Officials

  • JangHee Hong, PhD.

    Chungnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 5, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

KR(1)