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

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Cilnidipine/Valsartan; Drug: Cilnidipine+Valsartan

• Registration Number: NCT02343250
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-21
• Study Start: 2015-03
• Primary Completion: 2015-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

Inclusion Criteria

• Age between 20 and 40
• Signed informed consent

Exclusion Criteria

• Has a history of hypersensitivity to IP ingredients
• Hypertension of hypotension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cilnidipine+Valsartan	Cilnidipine/Valsartan	coadministration of cilinidipine and valsartan
Cinidipine/Valsartan tablet	Cilnidipine+Valsartan	Cinidipine/Valsartan tablet
Cinidipine/Valsartan tablet	Cilnidipine/Valsartan	Cinidipine/Valsartan tablet
Cilnidipine+Valsartan	Cilnidipine+Valsartan	coadministration of cilinidipine and valsartan

Primary Outcome Measures

Name	Time	Method
AUClast	0~24hr
Cmax	0~24hr