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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00501865 |
The rationale of this study is to assess whether or not food affects the absorption of GW273225 into the blood of healthy male and female volunteers in order to evaluate whether or not this drug should be given at a certain time relative to the consumption of food.
Condition | Intervention | Phase |
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Bipolar Disorder Epilepsy |
Drug: GW273225 |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | An Open, Randomised, Two-Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of GW273225 Administered Immediately After Food and Administered in the Fasted State to Healthy Male and Female Volunteers. |
Enrollment: | 14 |
Study Start Date: | August 2007 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Cambridgeshire | |
GSK Investigational Site | |
Cambridge, Cambridgeshire, United Kingdom, CB3 7TR |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | NAP109169 |
Study First Received: | July 13, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00501865 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
GW273225, food effect, quantitative pharmacokinetic analysis, healthy volunteers |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Epilepsy Mood Disorders |
Central Nervous System Diseases Psychotic Disorders Healthy Brain Diseases |
Nervous System Diseases |