Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00803673 |
This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in healthy volunteers
Condition | Intervention | Phase |
---|---|---|
Healthy Volunteer |
Drug: 1000mcg Drug: 100mcg Drug: 500mcg Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study |
Official Title: | A Single Centre, Randomized ,Double-Blind, Dose Ascending, Placebo-Controlled Study, in Two Parts, to Evaluate the Safety, Tolerability and Pharmacokinetics of Escalating Single and Repeat Inhaled Doses of GSK573719 and Placebo Formulated With the Excipient Magnesium Stearate, in Healthy Subjects an |
Enrollment: | 36 |
Study Start Date: | May 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active 2: Experimental
500mcg '719
|
Drug: 500mcg
500mcg '719
|
Active: Experimental
100mcg 719
|
Drug: 100mcg
100mcg '719
|
Active 3: Experimental
1000mcg '719
|
Drug: 1000mcg
1000mcg '719
|
Placebo: Placebo Comparator
Placebo '719
|
Drug: Placebo
Placebo '719
|
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: | 110106 |
Study First Received: | December 4, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00803673 |
Health Authority: | Belgium: Institutional Review Board |
Healthy volunteers New formulation |
Healthy |