Bioavailability of Dipyridamole of Asasantin p.o. in Three Experimental Formulations Relative to the Standard Formulation in Healthy Male Subjects
NCT02273557 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2014-10-24
Summary
The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with BID treatment
Conditions
- Healthy
Interventions
- DRUG
-
Asasantin ER (new formulation I - low)
- DRUG
-
Asasantin ER (new formulation III - medium)
- DRUG
-
Asasantin ER (new formulation II - high)
- DRUG
-
Asasantin ER (present commercial formulation)
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2003-01-31
- Primary Completion
- 2003-02-28
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