NCT02140489

Brief Summary

The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers.

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
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Feb 2014

Typical duration for phase_1 healthy

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

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

March 9, 2014

Last Update Submit

May 15, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Cmax

    0-72h

  • AUClast

    0-72h

Secondary Outcomes (3)

  • tmax

    0-72h

  • t1/2

    0-72h

  • AUCinf

    0-72h

Study Arms (3)

Sequence 1

EXPERIMENTAL

amosartan → rosuvastatin → amosartan and rosuvastatin

Drug: amosartanDrug: rosuvastatinDrug: amosartan and rosuvastatin

Sequence 2

EXPERIMENTAL

rosuvastatin → amosartan and rosuvastatin → amosartan

Drug: amosartanDrug: rosuvastatinDrug: amosartan and rosuvastatin

Sequence 3

EXPERIMENTAL

amosartan and rosuvastatin → amosartan → rosuvastatin

Drug: amosartanDrug: rosuvastatinDrug: amosartan and rosuvastatin

Interventions

amosartanDRUG
Also known as: amosartan, P.O
Sequence 1Sequence 2Sequence 3
rosuvastatinDRUG
Also known as: rosuvastatin, P.O
Sequence 1Sequence 2Sequence 3
amosartan and rosuvastatinDRUG
Also known as: amosartan and rosuvastatin, P.O
Sequence 1Sequence 2Sequence 3

Eligibility Criteria

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

You may qualify if:

  • Healthy male
  • Age between 19 and 55
  • Signed informed consent

You may not qualify if:

  • Presence of medical history or a concurrent disease
  • Has a history of hypersensitivity to IP ingredients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samgsung Seoul Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

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

Study Officials

  • JaeWook Ko, M.D.

    Samsung Seoul Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-A Jung, Ph.D

CONTACT

jajung@hanmi.co.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

March 9, 2014

First Posted

May 16, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

KR(1)