A Bioavailability Study Comparing 3 Different AZD1981 Tablets

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.

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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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Treatment A

Group Type EXPERIMENTAL

AZD1981, current small-particle tablet

Intervention Type DRUG

3x100 mg per oral, single dose in fasted state

Treatment B

Group Type EXPERIMENTAL

AZD1981, new small-particle tablet

Intervention Type DRUG

3x100 mg per oral, single dose

Treatment C

Group Type EXPERIMENTAL

AZD1981, new small-particle tablet

Intervention Type DRUG

3x100 mg per oral, single dose

Treatment D

Group Type EXPERIMENTAL

AZD1981, new large-particle table

Intervention Type DRUG

3x100 mg per oral, single dose in fasted state

Interventions

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AZD1981, current small-particle tablet

3x100 mg per oral, single dose in fasted state

Intervention Type DRUG

AZD1981, new small-particle tablet

3x100 mg per oral, single dose

Intervention Type DRUG

AZD1981, new large-particle table

3x100 mg per oral, single dose in fasted state

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive
* Have a body mass index between 19-30 kg/m2 and weigh at least 50 kg and no more than 100 kg, inclusive
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to screening
* Volunteers must be willing to use barrier methods of contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods.

Exclusion Criteria

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2
* Prolonged QTcF \>450 ms or shortened QTcF\<340 ms at Visit 1 or family history of long QT syndrome
* History of, or current alcohol or drug abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes