Reflux Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled, Two-centre, Phase IIa Pharmacodynamic Cross-over Study to Assess the Effect of AZD2516 on the Total Number of Reflux Episodes in Healthy Male Volunteers
The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Provision of signed informed consent - Healthy male subjects - Age 18-45 years, inclusive Exclusion Criteria: - Clinically significant illness within the 2 weeks prior to the first dose of study drug - History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal disease - Need for concomitant medications during the study |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Belgium | Research Site | Leuven | |
Netherlands | Research Site | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Belgium, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reflux Episodes 0 to 3 Hours Post Meal | Total number of reflux episodes 0 to 3 hours post meal | 0 to 3 hours post meal | No |
Secondary | Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal | Number of TLESRs 0 to 3 hours post meal were calculated based upon the manometric analysis fpr the 3-hour post-meal period. | 0 to 3 hours post meal | No |
Secondary | Area Under the Plasma Concentration Curve(AUC) | Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method | 0 to 12 hours post dose | No |
Secondary | Average Plasma Concentration (C Average) | Average plasma concentration | 1 to 4 hours post dose | No |
Secondary | Maximum Plasma Concentration (Cmax) | Maximum plasma concentration | 0 to 12 hours post dose | No |
Secondary | Time to Maximum Plasma Concentration (Tmax) | Time to maximum plasma concentration (Tmax) | 0 to 12 hours post dose | No |
Secondary | Terminal Half-life (T Half) | Terminal half-life (T half) | 0 to 12 hours post dose | No |
Secondary | Clinically Relevant Change of Laboratory Variables | Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer. | Pre-entry to follow-up | Yes |
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