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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00754715 |
The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.
Condition | Intervention | Phase |
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Healthy |
Drug: AZD2516 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
Official Title: | A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 in Young and Elderly Healthy Volunteers After Oral Single Ascending Doses |
Estimated Enrollment: | 72 |
Study Start Date: | September 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AZD2516: Experimental |
Drug: AZD2516
Solution administered once orally
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Placebo: Placebo Comparator |
Drug: Placebo
Solution administered only once
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Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca Pharmaceuticals ( Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia ) |
Study ID Numbers: | D2080C00001, EudractCT: 2008-003598-42 |
Study First Received: | September 16, 2008 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00754715 |
Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board |
Multiple dosing study, safety |
Healthy |