Drug Interaction Study Between AZD3355 and Nexium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00684190
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : December 3, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: AZD3355 Drug: Esomeprazole Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open, Randomised, Three Period Cross, Single Centre, Phase 1 Pharmacokinetic Interaction Study of the Reflux Inhibitor AZD3355 150 mg Bid and Esomeprazole 40 mg od After 7 Days of Treatment in Healthy Volunteers
Study Start Date : March 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions GERD

Arm Intervention/treatment
Experimental: 1
AZD3355 150 mg
Drug: AZD3355
150 mg bid, oral, 7 days
Other Name: Lesogaberan

Experimental: 2
Esomeprazole 40mg
Drug: Esomeprazole
40 mg od, oral, 7 days
Other Name: Nexium

Experimental: 3
AZD3355 150mg/Esomeprazole 40mg
Drug: AZD3355
150 mg bid, oral, 7 days
Other Name: Lesogaberan

Drug: Esomeprazole
40 mg od, oral, 7 days
Other Name: Nexium

Primary Outcome Measures :
  1. PK variables [ Time Frame: Frequent sampling occasions during day 7 each treatment period ]

Secondary Outcome Measures :
  1. 4-BOH cholesterol [ Time Frame: Sampling occasions during day 7 one treatment period (AZD3355 alone) ]
  2. Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00684190

Research Site
Uppsala, Sweden
Sponsors and Collaborators
Study Director: Eva Ersdal, PhD AstraZeneca R&D, Mölndal, Sweden
Principal Investigator: Jan Vouis, MD Quintiles AB, Uppsala, Sweden

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals Identifier: NCT00684190     History of Changes
Other Study ID Numbers: D9120C00016
EudraCt nr 2007-007128-16
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Reflux Inhibitor
PPI Interaction

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs