Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: AZD0837

Study type

Interventional

Funder types

Industry

Identifiers

NCT00878618
D1250C00056

Details and patient eligibility

About

The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy subject aged between 18 to 45 years inclusive
  • Body mass index (BMI) between 19 to 30 kg/m2 inclusive
  • Body weight between 50 to 100 kg inclusive
  • Women must be either post-menopausal, permanently sterilised or, if of childbearing potential, must have a negative pregnancy test before intake of study medication and use a reliable form of contraception before and during participation in the study.

Exclusion criteria

  • Significant illness (including ongoing or history of liver disease), trauma or surgical procedures from 2 weeks before the pre-entry visit until the first administration of Investigational Product
  • Clinical significant abnormalities in clinical chemistry, haematology or urinalysis result including positive result on screening tests for serum hepatitis B surface antigen, hepatitis C antibody or HIV or positive F-Hb result pre-entry
  • History of bleeding disturbance (including extensive menstrual bleedings) or thrombotic disorder
  • Clinically significant medical history, as judged by the investigator, including psychiatric disorders or severe allergies.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

36 participants in 4 patient groups

HAB
Experimental group
Description:
AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast
Treatment:
Drug: AZD0837
HBA
Experimental group
Description:
AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast
Treatment:
Drug: AZD0837
LAB
Experimental group
Description:
AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast
Treatment:
Drug: AZD0837
LBA
Experimental group
Description:
AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast
Treatment:
Drug: AZD0837

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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