Drug Interaction Study Between AZD3355 and Nexium
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
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 22, 2008
CompletedFirst Posted
Study publicly available on registry
May 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedDecember 3, 2010
December 1, 2010
3 months
May 22, 2008
December 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK variables
Frequent sampling occasions during day 7 each treatment period
Secondary Outcomes (2)
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
Study Arms (3)
1
EXPERIMENTALAZD3355 150 mg
2
EXPERIMENTALEsomeprazole 40mg
3
EXPERIMENTALAZD3355 150mg/Esomeprazole 40mg
Interventions
Eligibility Criteria
You may qualify if:
- Provision of written informed consent
- Females no childbearing potential
- Clinically normal physical findings
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Uppsala, Sweden
Related Publications (1)
Niazi M, Silberg DG, Miller F, Ruth M, Holmberg AA. Evaluation of the pharmacokinetic interaction between lesogaberan (AZD3355) and esomeprazole in healthy subjects. Drugs R D. 2010;10(4):243-51. doi: 10.2165/11588180-000000000-00000.
PMID: 21171670DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eva Ersdal, PhD
AstraZeneca R&D, Mölndal, Sweden
- PRINCIPAL INVESTIGATOR
Jan Vouis, MD
Quintiles AB, Uppsala, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 22, 2008
First Posted
May 26, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
December 3, 2010
Record last verified: 2010-12