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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00483535 |
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.
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: GW273225 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
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 |
Enrollment: | 12 |
Study Start Date: | March 2007 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
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, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | NEC107110 |
Study First Received: | June 6, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00483535 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Gw273225, Oral Contraceptive Interaction |
Healthy |