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Study to Compare Different Formulations of AZD3355

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00688402
First received: May 30, 2008
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
 Drug: AZD3355
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae After Dosing in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Specific AE questions [ Time Frame: During 0-4 hours post dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK variables [ Time Frame: Frequent sampling up to 36 hours post dose ] [ Designated as safety issue: No ]
  • Safety variables (other adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: April 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
IR Formulation 65 mg
 Drug: AZD3355
Single dose
Other Name: Lesogaberan
Experimental: 2
IR Formulation 150 mg
 Drug: AZD3355
Single dose
Other Name: Lesogaberan
Experimental: 3
MR formulation, 1h 65 mg
 Drug: AZD3355
Single dose
Other Name: Lesogaberan
Experimental: 4
MR Formulation, 1h 150 mg
 Drug: AZD3355
Single dose
Other Name: Lesogaberan
Experimental: 5
MR Formulation, 2h 150 mg
 Drug: AZD3355
Single dose
Other Name: Lesogaberan

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688402

Locations
Sweden
Research Site
Varvsgatan, Lulea, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva Ersdal, PhD AstraZeneca R&d, Mölndal, Sweden
Principal Investigator: Aslak Rautio, MD Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden
  More Information

No publications provided

Responsible Party: Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00688402     History of Changes
Other Study ID Numbers: D9120C00031, EudraCT nr 2007-007126-22
Study First Received: May 30, 2008
Last Updated: December 2, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Reflux Inhibitor
GERD
formulations

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

ClinicalTrials.gov processed this record on May 22, 2013