Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00713271 |
The purpose of this study is to investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men
Condition | Intervention | Phase |
---|---|---|
Healthy Volunteers |
Drug: AZD3199 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
Official Title: | A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD3199 (a B2-Agonist) Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men |
Estimated Enrollment: | 27 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Low dose
|
Drug: AZD3199
Low dose Dry powder for inhalation, o.d., 1+12 days |
2: Experimental
intermediate dose
|
Drug: AZD3199
intermediate dose Dry powder for inhalation, o.d., 1+12 days |
3: Experimental
high dose
|
Drug: AZD3199
high dose Dry powder for inhalation, o.d., 1+12 days |
4: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca R&D ( Lars Grundemar, MD, Medical Science Director, Emerging Respiratory 3 ) |
Study ID Numbers: | D0570C00002 |
Study First Received: | July 9, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00713271 |
Health Authority: | Sweden: Medical Products Agency |
Healthy male tolerability safety inhalation |
Healthy |