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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:

AUClast

Cmax

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

Page last updated: August 20, 2015

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