NCT02343250

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: IlDong Pharmaceutical Co Ltd · Industry
• Sex: Male
• Age: 19 Years – 40 Years
• Healthy volunteers: Accepted

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

• Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-03-01
• First posted: 2015-01-21
• Last updated: 2016-01-13