Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients
NCT ID: NCT01103622
Last Updated: 2011-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2010-06-30
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigate the Effect of AZD1656 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Type 2 Diabetes Mellitus (T2DM) Patients
NCT01103609
Investigate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa in Type 2 Diabetes Mellitus
NCT01082120
Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin
NCT01096940
To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Metformin
NCT00774553
To Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656
NCT01083212
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
twice daily Day 1 to Day 7; digoxin on day 4
AZD1656
Oral tablet bd, step-wise increased dosage
Digoxin
Oral tablet od on Day 4
2
twice daily Day 1 to Day 7; digoxin on day 4.
Digoxin
Oral tablet od on Day 4
Placebo
Oral tablet bd, step-wise increased dosage
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD1656
Oral tablet bd, step-wise increased dosage
Digoxin
Oral tablet od on Day 4
Placebo
Oral tablet bd, step-wise increased dosage
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index between ≥19 and ≤42 kg/m2.
* Haemoglobin (Hb) A1c ≥6.5% and ≤9.5% at enrolment.
Exclusion Criteria
* Systolic blood pressure \>160 mmHg or diastolic blood pressure \>95 mmHg at screening
* Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
AstraZeneca
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stanko Skrtic
Role: STUDY_DIRECTOR
AstraZeneca
Christoph Kapitza
Role: PRINCIPAL_INVESTIGATOR
Profil Institut für Stoffwechselforschung GmbH
Mirjana Kujacic
Role: STUDY_CHAIR
AstraZeneca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Chula Vista, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D1020C00031
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.