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Clinical Trial Details

Trial ID: L6294
Source ID: NCT01103609
Associated Drug: Warfarin
Title: Investigate the Effect of AZD1656 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Type 2 Diabetes Mellitus (T2DM) Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Warfarin|DRUG: Placebo|DRUG: AZD1656
Outcome Measures: Primary: To evaluate the pharmacokinetics of warfarin after a single dose when administered alone and in combination with AZD1656 at steady state by assessment of AUC and Cmax of both enantiomers of warfarin (S- and R-warfarin)., Serial PK blood samples will be taken on days 4-10 during the treatment periods | Secondary: To evaluate the anticoagulant activity of warfarin upon co-administration with AZD1656 by assessment of prothrombin time (PT) and international normalised ratio (INR)., Serial blood samples for warfarin PD measurements will be taken on days 4-10 during the treatment periods|To evaluate the safety of AZD1656 in combination with warfarin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events, Safety assessments will be monitored throughout the study, from screening visit until follow up visit.|To describe the pharmacokinetics of AZD1656 and its metabolite during concomitant warfarin administration by assessment of AUC0-24, Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only)., Serial PK blood samples will be taken on days 4-10 during the treatment periods
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-04
Completion Date: 2010-08
Results First Posted:
Last Update Posted: 2010-11-07
Locations: Research Site, London, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01103609