A bioavailability study comparing modified-release capsules and immediate release capsules in fed and fasting conditions
Study identifier:D1950C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2009-017702-36
CTIS identifier:N/A
Study Complete
Official Title
A Phase I study to investigate the relative bioavailability of modified-release formulations of AZD1446 compared to an immediate-release capsule under fed and fasting conditions following single and repeated dose administration to young and elderly healthy volunteers
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1446, Placebo
Sex
All
Actual Enrollment
62
Study type
Interventional
Age
18 Years - 80 Years
Date
Study Start Date: 01 Feb 2010
Primary Completion Date: 01 Jul 2010
Study Completion Date: 01 Jul 2010
Study design
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1 (2 arms) Period 1: randomized to either fasting IR or ER1. Period 2: Cross-over to either IR or ER1. Period 3: ER1 in fed conditions. | Drug: AZD1446 ER Fast, 90mg, p.o. capsule |
| Experimental: Cohort 2 (2 arms) Period 1: randomized to either fasting IR or ER2. Period 2: Cross-over to either IR or ER2. Period 3: ER2 in fed conditions. | Drug: AZD1446 ER Moderate, 90mg, p.o. capsule |
| Experimental: Cohort 3( 2 arms) Period 1: randomized to either fasting IR or ER3. Period 2: Cross-over to either IR or ER3. Period 3: ER3 in fed conditions. | Drug: AZD1446 ER Slow, 90mg, p.o. capsule |
| Experimental: Cohort 4 (2 arms) Period 1: randomized to either fasting IR or MR4. Period 2: Cross-over to either IR or MR4. Period 3: MR4 in fed conditions. | Drug: AZD1446 MR Drug: AZD1446 IR, 90 mg p.o. capsule |
| Experimental: Part 2: Extended/Modified release Extended/Modified release capsule to be determined | Drug: AZD1446 MR Drug: AZD1446 IR, 90 mg p.o. capsule |
| Placebo Comparator: Part 2: Placebo | Drug: Placebo IR Drug: Placebo ER/MR |
Contacts
Investigators
Principal Investigator
Lena Bolin
AstraZeneca R&D
