Study to assess effect of Cyclosporine on the blood levels of Ticagrelor
Study identifier:D5130C00074
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Single-Center,Open-Label,Randomized,3-Treatment,3-Period Cross-Over Study to Investigate the Potential Effect of Cyclosporine on the Pharmacokinetics, Safety, and Tolerability of Ticagrelor and the Effect of Ticagrelor on the Pharmacokinetics, Safety, and Tolerability of Cyclosporine
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
cyclosporine, ticagrelor
Sex
Male
Actual Enrollment
20
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Jan 2012
Primary Completion Date: 01 Jun 2012
Study Completion Date: 01 Jun 2012
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jun 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: A cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor | Drug: cyclosporine Oral tablets, 600 mg , single dose Drug: ticagrelor Oral tablets, 180 mg, single dose |
| Experimental: B single dose cyclosporine 600 mg | Drug: cyclosporine Oral tablets, 600 mg , single dose |
| Experimental: C single dose 180 mg ticagrelor | Drug: ticagrelor Oral tablets, 180 mg, single dose |
Contacts
Investigators
Principal Investigator
Miriana Kujacic
Molndal, Sweden AstraZeneca
