Bioequivalence of Two Different Polymorphs of Dabigatran Etexilate in Healthy Male and Female Volunteers
NCT02171481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2014-06-24
Summary
To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and polymorph II
Conditions
- Healthy
Interventions
- DRUG
-
Dabigatran etexilate polymorph II
- DRUG
-
Dabigatran etexilate polymorph I
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 60 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2008-08-31
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