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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HAB

AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast

Group Type EXPERIMENTAL

AZD0837

Intervention Type DRUG

Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days

HBA

AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast

Group Type EXPERIMENTAL

AZD0837

Intervention Type DRUG

Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days

LAB

AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast

Group Type EXPERIMENTAL

AZD0837

Intervention Type DRUG

Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days

LBA

AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast

Group Type EXPERIMENTAL

AZD0837

Intervention Type DRUG

Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days

Interventions

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AZD0837

Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days

Intervention Type DRUG

AZD0837

Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes