Relative Bioavailability of Phase II and Phase III Formulations of AZD0530

NCT ID: NCT00771979

Last Updated: 2009-06-18

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to compare how different formulations of AZD0530 are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.

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.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

AZD0530

Intervention Type DRUG

of both the Phase II and Phase III AZD0530 125mg tablet variants (A and B) in a random order.

AZD0530

Intervention Type DRUG

Part II: Single doses of AZD0530 125mg oral solution and 2 out of 4 125mg tablet variants (C, D, E and F) in a random order.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD0530

of both the Phase II and Phase III AZD0530 125mg tablet variants (A and B) in a random order.

Intervention Type DRUG

AZD0530

Part II: Single doses of AZD0530 125mg oral solution and 2 out of 4 125mg tablet variants (C, D, E and F) in a random order.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female subjects must be of Non- child-bearing potential
* Body mass index between 19 and 30 kg/m2 and weigh between 50-100 kg

Exclusion Criteria

* Presence of any clinically significant illness
* Abnormal vital signs
* History of any conditions that may put the subject at risk by participating in the study
* Participation in another clinical study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca Pharmaceuticals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raj Chetty, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca, Clinical Pharmacology Unit, Alderley Park

Mary Stuart, MD

Role: STUDY_DIRECTOR

AstraZeneca,Parklands, Alderley Park

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Alderley Park, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D8180C00033

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AZD5672 Absolute Bioavailability Study
NCT00746837 COMPLETED PHASE1
Pharmacokinetics of AZD7295 Capsules
NCT01097408 COMPLETED PHASE1
AZD6280 Multiple Ascending Dose Study
NCT00681317 COMPLETED PHASE1