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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088008
Recruitment Status : Unknown
Verified March 2014 by IlDong Pharmaceutical Co Ltd.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: cinidipine, valsartan Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2014
Estimated Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Arms and Interventions
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Arm Intervention/treatment
Experimental: cilnidipine/valsartan
cilnidipine/valsartan tablet
 Drug: cinidipine, valsartan
Active Comparator: cilnidipine+valsartan
coadministration of cilnidipine and valsartan
 Drug: cinidipine, valsartan


Outcome Measures
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Primary Outcome Measures :
  1. AUClast [ Time Frame: 0~24hrs ]
  2. Cmax [ Time Frame: 0~24hrs ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 20 and 40
  • Signed informed consent

Exclusion Criteria:

  • Has a history of hypersensitivity to IP ingredients
  • Hypertension or hyportension
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088008


Contacts
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Contact: yoan park 82-2-526-3524 yapark@ildong.com

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Contact: Kyungsang Yu         
Principal Investigator: Kyungsang Yu         
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd
More Information
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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02088008    
Other Study ID Numbers: ID_IDCV_1303
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action