Anticoagulant Effect of Warfarin When Taken With Duloxetine.
Conditions
Brief summary
To evaluate the blood clotting effects of multiple doses of warfarin at steady state when taken at the same time as multiple doses of duloxetine as measured by changes in the International Normalised Ratio. All subjects will begin dosing with warfarin, then after approximately 12 days, duloxetine 60 mg is added and subjects with stabilized INR will either continue dosing at 60 mg or have a dose increase to 120 mg.
Interventions
DRUGDuloxetine
DRUGWarfarin
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy men or women between ages 18 and 64 years.
Exclusion criteria
Have a personal history, family history of, or current evidence of: a bleeding disorder, have Positive Faecal Occult Blood (FOB) sample at screening, significant neuropsychiatric disease (including a history of suicide attempts or who have exhibited suicidal ideation or who are at significant risk to commit suicide, as judged by the investigator), significant active respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders. Use or intended use of aspirin or NSAIDs within 2 weeks prior to first dosing. Subjects who have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females). Subjects who smoke more than 5 cigarettes per day. Use or intended us of a drug that inhibits or induces CYP1A2 or inhibits CYP2D6 within 2 weeks prior to first dosing occasion or during the study. Have received any drug that acts as a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to first dosing occasion or have a potential need to use an MAOI during the conduct of this study or within 2 weeks after discontinuation of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Normalized Ratio (INR) | 58 days |
Secondary
| Measure | Time frame |
|---|---|
| Effect of duloxetine on pharmacokinetics of warfarin. | 58 days |
| Safety/ tolerability of duloxetine and warfarin given in combination. | 58 days |
| Bleeding times when duloxetine and warfarin are given in combination. | 58 days |
Countries
United Kingdom
Outcome results
None listed