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Completed

NCT Number: NCT00771979

Relative Bioavailability of Phase II and Phase III Formulations of AZD0530

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Alderley Park, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD0530

Drug

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

Primary outcomes

  1. To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation.

    Time frame: 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 outcomes

  1. To monitor the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events.

    Time frame: From time of consent to last visit.

  2. 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

    Time frame: Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Study completion
2009
First posted
Oct 15, 2008
Registry last updated
Jun 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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