Relative Bioavailability of Phase II and Phase III Formulations of AZD0530

A Phase I, Randomised, Open-Label, Cross-Over, Single Centre Study in Healthy Volunteers to Determine the Relative Bioavailability of the Phase III Tablet Formulation to the Phase II Tablet Formulation of AZD0530

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00771979

Enrollment

Registered

2008-10-15

Start date

2008-11-30

Completion date

2009-03-31

Last updated

2009-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Volunteers, Relative Bioavailability

Brief summary

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.

Interventions

DRUGAZD0530

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation.	Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.

Secondary

Measure	Time frame
To monitor the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events.	From time of consent to last visit.
An exploratory objective is to characterise the Pharmacokinetic profile of an oral solution of AZD0530 and 4 additional tablet variants of the Phase III formulation of AZD0530	Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026