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NCT02088008 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02088008
Other study ID # ID_IDCV_1303
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received March 10, 2014
Last updated March 12, 2014
Start date May 2014

Study information
Verified date March 2014
Source IlDong Pharmaceutical Co Ltd
Contact yoan park
Phone 82-2-526-3524
Email yapark@ildong.com
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 54
Est. completion date
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• cinidipine, valsartan

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUClast 0~24hrs Yes
Primary Cmax 0~24hrs Yes
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