A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and Valsartan
Information source: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Cilnidipine/Valsartan (Drug); Cilnidipine+Valsartan (Drug); Cilnidipine/Valsartan (Drug); Cilnidipine+Valsartan (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: IlDong Pharmaceutical Co Ltd Official(s) and/or principal investigator(s):
Kyungsang Yu, PhD, Principal Investigator, Affiliation: Seoul National University Hospital
Overall contact:
SEUNG YEON YOU, Phone: 82-2-526-3320, Ext: 320, Email: sy-since83@ildong.com
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUClastCmax
Eligibility
Minimum age: 19 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Age between 20 and 40
- Signed informed consent
Exclusion Criteria:
- Has a history of hypersensitivity to IP ingredients
- Hypertension of hypotension
Locations and Contacts
SEUNG YEON YOU, Phone: 82-2-526-3320, Ext: 320, Email: sy-since83@ildong.com Additional Information
Starting date: March 2015
Last updated: January 15, 2015
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