Bipolar Disorder Clinical Trial
Official title:
An Open, Repeat Dose Study to Investigate the Effect of Co-administration of the Combined Oral Contraceptive Pill (COC) and GW273225 on the Pharmacokinetics of the COC and to Investigate the Effects of the COC on the Pharmacokinetics of GW273225 in Healthy Female Subjects
GW273225 is in development for epilepsy and bipolar disorder and can affect women of child
bearing potential. A clear understanding of the potential interaction between oral
contraceptives and GW273225 is therefore important for clinical investigation of GW273225 in
a large number of patients. This study will investigate whether there is any effect of
GW273225 upon the components of combined oral contraceptive, and also whether taking oral
contraceptives affects the pharmacokinetics (PK) of GW273225.
26 healthy female subjects, aged 18-45 years will take an oral contraceptive (150ug
levonorgestrel and 30ug ethinylestrdiol; The study will include a screening period, two
cycles on oral contraceptive with GW273225 at 25 mg once per day administered from the start
of the second COC cycle for 47 days. There will be a follow-up visit 14-21 days later.
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