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Clinical Trials/NCT02088008
NCT02088008
Unknown
Phase 1

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

IlDong Pharmaceutical Co Ltd1 site in 1 country54 target enrollmentMay 2014
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ConditionsHealthy Volunteers
Interventionscinidipine, valsartan
Drugscinidipine, valsartan

Overview

Phase
Phase 1
Intervention
cinidipine, valsartan
Conditions
Healthy Volunteers
Sponsor
IlDong Pharmaceutical Co Ltd
Enrollment
54
Locations
1
Primary Endpoint
Cmax
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
September 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Age between 20 and 40
  • •Signed informed consent

Exclusion Criteria

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

Arms & Interventions

cilnidipine/valsartan

cilnidipine/valsartan tablet

Intervention: cinidipine, valsartan

cilnidipine+valsartan

coadministration of cilnidipine and valsartan

Intervention: cinidipine, valsartan

Outcomes

Primary Outcomes

Cmax

Time Frame: 0~24hrs

AUClast

Time Frame: 0~24hrs

Study Sites (1)

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