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

IlDong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: cinidipine, valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02088008

ID_IDCV_1303

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 estimated patients

Sex: Male

Ages: 20 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 or hyportension

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

cilnidipine/valsartan

Experimental group

Description:

cilnidipine/valsartan tablet

Treatment:

Drug: cinidipine, valsartan

cilnidipine+valsartan

Active Comparator group

Description:

coadministration of cilnidipine and valsartan

Treatment:

Drug: cinidipine, valsartan