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

NCT ID: NCT02343250

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cinidipine/Valsartan tablet

Cinidipine/Valsartan tablet

Group Type EXPERIMENTAL

Cilnidipine/Valsartan

Intervention Type DRUG

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

Cilnidipine+Valsartan

Intervention Type DRUG

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

Cilnidipine+Valsartan

coadministration of cilinidipine and valsartan

Group Type ACTIVE_COMPARATOR

Cilnidipine+Valsartan

Intervention Type DRUG

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

Cilnidipine/Valsartan

Intervention Type DRUG

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

Interventions

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Cilnidipine/Valsartan

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

Intervention Type DRUG

Cilnidipine+Valsartan

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

Intervention Type DRUG

Cilnidipine/Valsartan

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

Intervention Type DRUG

Cilnidipine+Valsartan

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 20 and 40
* Signed informed consent

Exclusion Criteria

* Has a history of hypersensitivity to IP ingredients
* Hypertension of hypotension
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyungsang Yu, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Related Links

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Other Identifiers

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ID-IDCV-103

Identifier Type: -

Identifier Source: org_study_id

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