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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02343250
Acronym
IDCV
Enrollment
54
Registered
2015-01-21
Start date
2015-03-31
Completion date
Unknown
Last updated
2016-01-13

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

Conditions

Hypertension

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

DRUGCilnidipine/Valsartan

Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle

DRUGCilnidipine+Valsartan

Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle

Sponsors

IlDong Pharmaceutical Co Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 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 of hypotension

Design outcomes

Primary

MeasureTime frame
AUClast0~24hr
Cmax0~24hr

Outcome results

None listed

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