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Drug Interaction Study Between AZD3355 and Nexium

NCT ID: NCT00684190

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of the study is to evaluate if AZD3355 and Nexium interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Keywords

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Reflux Inhibitor GERD PPI Interaction

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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1

AZD3355 150 mg

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

150 mg bid, oral, 7 days

2

Esomeprazole 40mg

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

40 mg od, oral, 7 days

3

AZD3355 150mg/Esomeprazole 40mg

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

150 mg bid, oral, 7 days

Esomeprazole

Intervention Type DRUG

40 mg od, oral, 7 days

Interventions

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AZD3355

150 mg bid, oral, 7 days

Intervention Type DRUG

Esomeprazole

40 mg od, oral, 7 days

Intervention Type DRUG

Other Intervention Names

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Lesogaberan Nexium

Eligibility Criteria

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Inclusion Criteria

* Provision of written informed consent
* Females no childbearing potential
* 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

Jan Vouis, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles AB, Uppsala, Sweden

Locations

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Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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Niazi M, Silberg DG, Miller F, Ruth M, Holmberg AA. Evaluation of the pharmacokinetic interaction between lesogaberan (AZD3355) and esomeprazole in healthy subjects. Drugs R D. 2010;10(4):243-51. doi: 10.2165/11588180-000000000-00000.

Reference Type DERIVED
PMID: 21171670 (View on PubMed)

Other Identifiers

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EudraCt nr 2007-007128-16

Identifier Type: -

Identifier Source: secondary_id

D9120C00016

Identifier Type: -

Identifier Source: org_study_id