Drug Interaction Study Between AZD3355 and Nexium

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: AZD3355; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00684190

EudraCt nr 2007-007128-16

D9120C00016

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

1

Experimental group

Description:

AZD3355 150 mg

Treatment:

Drug: AZD3355

2

Experimental group

Description:

Esomeprazole 40mg

Treatment:

Drug: Esomeprazole

3

Experimental group

Description:

AZD3355 150mg/Esomeprazole 40mg

Treatment:

Drug: Esomeprazole

Drug: AZD3355