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

NCT02343250 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-01-13

No results posted yet for this study

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

Conditions

Interventions

DRUG

Cilnidipine/Valsartan

Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle

DRUG

Cilnidipine+Valsartan

Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle

DRUG

Cilnidipine/Valsartan

Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle

DRUG

Cilnidipine+Valsartan

Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle

Sponsors & Collaborators

  • IlDong Pharmaceutical Co Ltd

    lead INDUSTRY

Principal Investigators

  • Kyungsang Yu, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02343250 on ClinicalTrials.gov