A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination Tablet With Coadministration of Cilnidipine and Valsartan

March 12, 2014 updated by: IlDong Pharmaceutical Co Ltd

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
        • Contact:
          • Kyungsang Yu
        • Principal Investigator:
          • Kyungsang Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age between 20 and 40
  • Signed informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cilnidipine/valsartan
cilnidipine/valsartan tablet
Drug: cinidipine, valsartan
Active Comparator: cilnidipine+valsartan
coadministration of cilnidipine and valsartan
Drug: cinidipine, valsartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUClast
Time Frame: 0~24hrs
0~24hrs
Cmax
Time Frame: 0~24hrs
0~24hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IlDong Pharmaceutical Co Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID_IDCV_1303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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