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

Phase 1UnknownNCT02088008

IlDong Pharmaceutical Co Ltd54 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

cinidipine, valsartanDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 20 and 40 * Signed informed consent Exclusion Criteria: * Has a history of hypersensitivity to IP ingredients * Hypertension or hyportension

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUClast

Time frame: 0~24hrs

Cmax

Time frame: 0~24hrs

Central Contacts

yoan park

CONTACT

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

Data from ClinicalTrials.gov

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