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

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

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 20 and 40
Signed informed consent

Exclusion criteria

Has a history of hypersensitivity to IP ingredients
Hypertension of hypotension

Treatment and study plan

Cilnidipine/Valsartan

Drug

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

Cilnidipine+Valsartan

Drug

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

Primary outcomes

AUClast

Time frame: 0~24hr
Cmax

Time frame: 0~24hr

Sponsors and collaborators

Lead sponsor

IlDong Pharmaceutical Co Ltd

Industry

Registry information

Official study title

Acronym: IDCV

Important dates

Study start: 2015
Primary completion: 2015
First posted: Jan 21, 2015
Registry last updated: Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed