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Clinical Trial Details

Trial ID: L6108
Source ID: NCT01103622
Associated Drug: Azd1656
Title: Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: AZD1656|DRUG: Digoxin|DRUG: Placebo
Outcome Measures: Primary: evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin, Serial PK blood samples will be taken on days 4-8 during the treatment periods | Secondary: evaluate the safety of AZD1656 in combination with digoxin 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.|describe the pharmacokinetics of AZD1656 and its metabolite during concomitant digoxin administration by assessment of AUC(0-24), Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only)., Serial PK blood samples will be taken on days 4-8 during the treatment periods|describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2., Serial PK blood samples will be taken on days 4-8 during the treatment periods
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-06
Completion Date: 2010-12
Results First Posted:
Last Update Posted: 2011-01-05
Locations: Research Site, Chula Vista, California, United States
URL: https://clinicaltrials.gov/show/NCT01103622