A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and Valsartan (IDCV)

IlDong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Cilnidipine+Valsartan; Drug: Cilnidipine/Valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02343250

ID-IDCV-103

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: Male

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 20 and 40
• Signed informed consent

Exclusion criteria

• Has a history of hypersensitivity to IP ingredients
• Hypertension of hypotension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Cinidipine/Valsartan tablet

Experimental group

Description:

Cinidipine/Valsartan tablet

Treatment:

Drug: Cilnidipine+Valsartan

Drug: Cilnidipine/Valsartan

Drug: Cilnidipine+Valsartan

Drug: Cilnidipine/Valsartan

Cilnidipine+Valsartan

Active Comparator group

Description:

coadministration of cilinidipine and valsartan

Treatment:

Drug: Cilnidipine+Valsartan

Drug: Cilnidipine/Valsartan

Drug: Cilnidipine+Valsartan

Drug: Cilnidipine/Valsartan