Drug Interaction Study Between AZD3355 and Nexium

Phase 1

Completed

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

• Registration Number: NCT00684190
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-26
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3	AZD3355	AZD3355 150mg/Esomeprazole 40mg
1	AZD3355	AZD3355 150 mg
2	Esomeprazole	Esomeprazole 40mg
3	Esomeprazole	AZD3355 150mg/Esomeprazole 40mg

Primary Outcome Measures

Name	Time	Method
PK variables	Frequent sampling occasions during day 7 each treatment period

Secondary Outcome Measures

Name	Time	Method
4-BOH cholesterol	Sampling occasions during day 7 one treatment period (AZD3355 alone)
Safety variables (adverse events, blood pressure, pulse, safety lab)	During the whole treatment period

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden