AZD1981 Bioavailability study of Intravenous (IV) and oral formulations
Study identifier:D9831C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open, Single-dose, Phase I, 4-period partly Crossover Study in Healthy Men or Women to Assess Relative Bioavailability of Oral Administration of AZD1981 via Tablets Compared with Suspension and Basic Systemic Pharmacokinetic Parameters after Intravenous Administration
Medical condition
Healthy, postmenopausal
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1981
Sex
All
Actual Enrollment
14
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: -
Study Completion Date: 01 Jul 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD1981, 100 mg iv infusion | Drug: AZD1981 100 mg iv infusion, single dose, 4 hours infusion |
| Experimental: 2 AZD1981, 514 mg oral solution | Drug: AZD1981 514 mg oral solution, single dose |
| Experimental: 3 AZD1981, 500 mg oral tablet A | Drug: AZD1981 500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose |
| Experimental: 4 AZD1981, 500 mg oral tablet B | Drug: AZD1981 500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose |
Contacts
Investigators
Principal Investigator
Eva Pettersson
AstraZeneca R&D, Lund, Sweden
