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A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade

2019-10-17 11:03:44 | BioPortfolio

Summary

Bioequivalence study between two inhaler products (discus) of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder

Description

A bioequivalence study of a single dose of the fixed-dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder administered from Fluticasone propionate 100 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and SERETIDE DISKUS® 100/50 mcg inhalation powder/GSK (reference-R) in healthy volunteers under fasting conditions with charcoal blockade. The study will be one-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.

Study Design

Conditions

Bioequivalence

Intervention

Test Product (Fluticasone propionate and salmeterol xinafoate inhalation powder/Respirent Pharmaceuticals), Reference Product (SERETIDE DISKUS® 100/50 inhalation powder/GSK), Activated Charcoal suspension

Location

BECRO Clinical Facility
Larissa
Thessaly
Greece
41100

Status

Recruiting

Source

Respirent Pharmaceuticals Co Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-17T11:03:44-0400

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Medical and Biotech [MESH] Definitions

A drug combination of fluticasone and salmeterol that is used as an inhaler formulation to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

A drug combination of fluticasone and salmeterol that is used as an inhaler formulation to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

A selective ADRENERGIC BETA-2 RECEPTOR agonist that functions as a BRONCHODILATOR when administered by inhalation. It is used to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

An ester of TESTOSTERONE with a propionate substitution at the 17-beta position.

A device that delivers medication to the lungs in the form of a dry powder.

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