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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00671216 |
GW642444 and GSK233705 are in development for treatment of Chronic Obstructive Pulmonary Disease. Development of these two inhaled drugs as a combination therapy would have potential for improved patient benefit as they both work through different mechanisms and the combined bronchodilatory effect might be additive. This study will look at the this combination, for the first time, in healthy subjects.
Condition | Intervention | Phase |
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Chronic Obstructive Pulmonary Disease (COPD) |
Drug: GSK233705 Drug: GW642444 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Safety Study |
Official Title: | A Single Centre, Randomised, Placebo-Controlled, Four-Way Cross Over Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK233705 and GW642444 as Monotherapies and in Combination in Healthy Subjects. |
Estimated Enrollment: | 16 |
Study Start Date: | May 2008 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | DB1111509 |
Study First Received: | April 30, 2008 |
Last Updated: | June 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00671216 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Muscarinic Receptor Antagonist Anticholinergic ß2 agonist healthy subjects safety |
tolerability pharmacokinetics pharmacodynamics GSK233705 GS642444 |
Oxymetazoline Lung Diseases, Obstructive Cholinergic Antagonists Respiratory Tract Diseases |
Phenylephrine Lung Diseases Healthy Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Pulmonary Disease, Chronic Obstructive |