A Bioavailability Study Comparing Modified-release Capsules and Immediate Release Capsules in Fed and Fasting Conditions
NCT ID: NCT01092299
Last Updated: 2010-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
62 participants
INTERVENTIONAL
2010-02-28
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Part 2: To asses the safety and tolerability of the selected formulation(s) from part 1 in elderly healthy volunteers.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.
NCT01951599
A Bioavailability and Food Effect Study of AZD5462 in Healthy Volunteers
NCT05512806
Phase I 2-Way Crossover Study to Assess Relative BA of Tablet Versus Liquid Suspension and Food Effect on Tablet Formulation
NCT00867685
A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations
NCT06996886
AZD9056 Relative Bioavailability Study
NCT00908934
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
AZD1446
ER Fast, 90mg, p.o. capsule
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.
AZD1446
ER Moderate, 90mg, p.o. capsule
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.
AZD1446
ER Slow, 90mg, p.o. capsule
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.
AZD1446
MR
AZD1446
IR, 90 mg p.o. capsule
Part 2: Extended/Modified release
Extended/Modified release capsule to be determined
AZD1446
MR
AZD1446
IR, 90 mg p.o. capsule
Part 2: Placebo
Placebo
IR
Placebo
ER/MR
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD1446
ER Fast, 90mg, p.o. capsule
AZD1446
ER Moderate, 90mg, p.o. capsule
AZD1446
ER Slow, 90mg, p.o. capsule
AZD1446
MR
AZD1446
IR, 90 mg p.o. capsule
Placebo
IR
Placebo
ER/MR
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinically normal findings on physical examination
Exclusion Criteria
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* History or present symptoms or signs of severe allergy/hypersensitivity reactions including severe food allergy, as judged by the investigator
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
AstraZeneca
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lena Bolin
Role: STUDY_DIRECTOR
AstraZeneca R&D
Aslak Rautio
Role: PRINCIPAL_INVESTIGATOR
Quintiles Hermelinen AB
Wolfgang Kühn
Role: PRINCIPAL_INVESTIGATOR
Quintiles AB, Phase I Services
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Luleå, , Sweden
Research Site
Uppsala, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-017702-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1950C00008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.