A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination Tablet 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

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02088008

Enrollment

Registered

2014-03-14

Start date

2014-05-31

Completion date

Unknown

Last updated

2014-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGcinidipine, valsartan

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Age between 20 and 40 * Signed informed consent

Exclusion criteria

* Has a history of hypersensitivity to IP ingredients * Hypertension or hyportension

Design outcomes

Primary

Measure	Time frame
AUClast	0~24hrs
Cmax	0~24hrs

Countries

South Korea

Contacts

Primary Contactyoan park

yapark@ildong.com82-2-526-3524

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026