NCT02088008

Brief Summary

A randomized, open-label, single dosing, two-way crossover clinical trial to compare the safety/tolerability and pharmacokinetics of the combination of Cilnidipine 10mg and Valsartan 160mg in comparison to each component coadministered in healthy male volunteers.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

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

First Submitted

Initial submission to the registry

March 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

4 months

First QC Date

March 10, 2014

Last Update Submit

March 12, 2014

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • AUClast

    0~24hrs

  • Cmax

    0~24hrs

Study Arms (2)

cilnidipine/valsartan

EXPERIMENTAL

cilnidipine/valsartan tablet

Drug: cinidipine, valsartan

cilnidipine+valsartan

ACTIVE COMPARATOR

coadministration of cilnidipine and valsartan

Drug: cinidipine, valsartan

Interventions

cinidipine, valsartanDRUG
cilnidipine+valsartancilnidipine/valsartan

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 40
  • Signed informed consent

You may not qualify if:

  • Has a history of hypersensitivity to IP ingredients
  • Hypertension or hyportension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Valsartan

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Central Study Contacts

yoan park

CONTACT

82-2-526-3524yapark@ildong.com

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 10, 2014

First Posted

March 14, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

KR(1)