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Clinical Trial Details

Trial ID: L3813
Source ID: NCT01096940
Associated Drug: Azd1656
Title: Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: AZD1656|DRUG: simvastatin
Outcome Measures: Primary: To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin (including simvastatin acid) and vice versa by assessment of AUC(0-24) and Cmax., Frequent blood samples for PK analysis will be drawn during 24 hours post morning dose on day 4 in each treatment period (1-3) | Secondary: To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin and simvastatin acid and vice versa by assessment of tmax, t1/2 and CL/F (only for AZD1656), Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)|To evaluate the steady state pharmacokinetics of the AZD1656 metabolite when AZD1656 is administered with and without simvastatin, by assessment of AUC(0-24), Cmax and tmax., Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)|To evaluate the effect of AZD1656 on the pharmacodynamics of simvastatin by assessment of AUC(0-t) and Cmax of active 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors., Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)|To evaluate the safety and tolerability of AZD1656 alone and in combination with simvastatin by assessments of adverse events, laboratory variables, electrocardiogram, blood pressure, pulse, results of physical examination, and weight., At pre entry, during the study days,
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 44
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
Start Date: 2010-03
Completion Date: 2010-08
Results First Posted:
Last Update Posted: 2010-11-07
Locations: Research Site, San Antonio, Texas, United States
URL: https://clinicaltrials.gov/show/NCT01096940