Study to Compare Different Formulations of AZD3355

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: AZD3355

Study type: Interventional

Funder types: Industry

Identifiers

NCT00688402

EudraCT nr 2007-007126-22

D9120C00031

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 5 patient groups

1

Experimental group

Description:

IR Formulation 65 mg

Treatment:

Drug: AZD3355

2

Experimental group

Description:

IR Formulation 150 mg

Treatment:

Drug: AZD3355

3

Experimental group

Description:

MR formulation, 1h 65 mg

Treatment:

Drug: AZD3355

4

Experimental group

Description:

MR Formulation, 1h 150 mg

Treatment:

Drug: AZD3355

5

Experimental group

Description:

MR Formulation, 2h 150 mg

Treatment:

Drug: AZD3355