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AZD5672 Bioavailability Study in Healthy Male and Female Subjects

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: AZD5672

Study type

Interventional

Funder types

Industry

Identifiers

NCT00871767
D1710C00019
EudraCt No. 2009-009423-10

Details and patient eligibility

About

The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies

Enrollment

24 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Provision of informed consent prior to any study-specific procedures
  • BMI between 18 and 30 kg/m2
  • Medical and surgical history and physical examination without any clinically significant findings
  • Non smokers or past smokers who have stopped smoking within the last 6 months.

Exclusion criteria

  • History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
  • Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product.
  • Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

Trial design

24 participants in 2 patient groups

1
Experimental group
Description:
40 or 100mg AZD5672, Reference formulation
Treatment:
Drug: AZD5672
2
Experimental group
Description:
40 or 100mg AZD5672, Test formulation
Treatment:
Drug: AZD5672

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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