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Study to Compare Different Formulations of AZD3355

NCT ID: NCT00688402

Last Updated: 2010-12-03

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-06-30

Brief Summary

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The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Keywords

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Reflux Inhibitor GERD formulations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

IR Formulation 65 mg

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

Single dose

2

IR Formulation 150 mg

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

Single dose

3

MR formulation, 1h 65 mg

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

Single dose

4

MR Formulation, 1h 150 mg

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

Single dose

5

MR Formulation, 2h 150 mg

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

Single dose

Interventions

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AZD3355

Single dose

Intervention Type DRUG

Other Intervention Names

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Lesogaberan

Eligibility Criteria

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Inclusion Criteria

* Provision of written informed consent
* Female subjects with no childbearing potentials or using highly efficient contraceptive methods
* Clinically normal physical findings

Exclusion Criteria

* Clinically significant illness within 2 weeks prior to the first dose of investigational product
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Eva Ersdal, PhD

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Aslak Rautio, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden

Locations

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Research Site

Varvsgatan, Lulea, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudraCT nr 2007-007126-22

Identifier Type: -

Identifier Source: secondary_id

D9120C00031

Identifier Type: -

Identifier Source: org_study_id