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A Study Comparing the Bioequivalence of Triamcinolone Acetonide Aqueous Nasal Spray (Apotex, Inc.) to That of Nasacort® AQ Nasal Spray (Sanofi-Aventis Pharmaceutical Products, Inc.) In the Treatment of Seasonal Allergic Rhinitis

2014-08-27 03:18:58 | BioPortfolio

Summary

A randomized, double-blind, placebo-controlled parallel-group study, comparing the bioequivalence of triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) to that of Nasacort® AQ nasal spray (Sanofi-Aventis Pharmaceutical Products, Inc.) in the treatment of seasonal allergic rhinitis.

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Seasonal Allergic Rhinitis

Intervention

triamcinolone acetonide aqueous nasal spray (Apotex Inc.), triamcinolone acetonide aqueous nasal spray (Nasacort® AQ), Placebo

Location

Clinsys Clinical Research, Inc.
Bedminster
New Jersey
United States
07921

Status

Completed

Source

Apotex Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:58-0400

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Medical and Biotech [MESH] Definitions

An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.

A synthetic progestational dihydroxy derivative of PROGESTERONE. Its acetonide possesses anti-inflammatory properties.

A glucocorticoid given, as the free alcohol or in esterified form, orally, intramuscularly, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. (From Martindale, The Extra Pharmacopoeia, 30th ed, p739)

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Local antibacterial that probably acts by releasing formaldehyde in aqueous solutions. It is used for irrigation of infected body cavities - bladder, peritoneum, etc. and as a spray for burns.

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