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

May 30, 2008
December 2, 2010
April 2008
June 2008   (final data collection date for primary outcome measure)
Specific AE questions [ Time Frame: During 0-4 hours post dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00688402 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Compare Different Formulations of AZD3355
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Gastroesophageal Reflux Disease
Drug: AZD3355
Single dose
Other Name: Lesogaberan
  • Experimental: 1
    IR Formulation 65 mg
    Intervention: Drug: AZD3355
  • Experimental: 2
    IR Formulation 150 mg
    Intervention: Drug: AZD3355
  • Experimental: 3
    MR formulation, 1h 65 mg
    Intervention: Drug: AZD3355
  • Experimental: 4
    MR Formulation, 1h 150 mg
    Intervention: Drug: AZD3355
  • Experimental: 5
    MR Formulation, 2h 150 mg
    Intervention: Drug: AZD3355
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00688402
D9120C00031, EudraCT nr 2007-007126-22
No
Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Director: Eva Ersdal, PhD AstraZeneca R&d, Mölndal, Sweden
Principal Investigator: Aslak Rautio, MD Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP