Study to Compare Different Formulations of AZD3355

Phase 1

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: AZD3355

• Registration Number: NCT00688402
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-05-30
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Posted: 2008-06-03
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3	AZD3355	MR formulation, 1h 65 mg
4	AZD3355	MR Formulation, 1h 150 mg
2	AZD3355	IR Formulation 150 mg
1	AZD3355	IR Formulation 65 mg
5	AZD3355	MR Formulation, 2h 150 mg

Primary Outcome Measures

Name	Time	Method
Specific AE questions	During 0-4 hours post dose

Secondary Outcome Measures

Name	Time	Method
PK variables	Frequent sampling up to 36 hours post dose
Safety variables (other adverse events, blood pressure, pulse, safety lab)	During the whole treatment period

Trial Locations

Locations (1)

Research Site; 🇸🇪 Varvsgatan, Lulea, Sweden