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

Phase 1

• Conditions: Healthy Volunteers
• Interventions: Drug: cinidipine, valsartan

• Registration Number: NCT02088008
• 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

• Status Verified: 2014-03
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-12
• Last Update Submitted: 2014-03-12
• Study First Posted: 2014-03-14
• Last Update Posted: 2014-03-14
• Study Start: 2014-05
• Primary Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• 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 or hyportension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
cilnidipine/valsartan	cinidipine, valsartan	cilnidipine/valsartan tablet
cilnidipine+valsartan	cinidipine, valsartan	coadministration of cilnidipine and valsartan

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of