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Drug Interaction Study Between AZD3355 and Nexium

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00684190
First Posted: May 26, 2008
Last Update Posted: December 3, 2010
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Gastroesophageal Reflux Disease Drug: AZD3355 Drug: Esomeprazole Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Enrollment: 30
Study Start Date: March 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00684190


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00684190     History of Changes
Other Study ID Numbers: D9120C00016
EudraCt nr 2007-007128-16
First Submitted: May 22, 2008
First Posted: May 26, 2008
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Reflux Inhibitor
GERD
PPI Interaction

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Lesogaberan
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