Pharmacokinetics and Relative Bioavailability of 11634 Immediate Release Tablet in Healthy Male Volunteers
NCT02214927 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2014-08-13
Summary
* Characterisation of the relative bioavailability of the IR-tablet vs. oral drinking solution (no primary endpoint in a statistical sense)
* Safety and tolerability of the IR-tablet formulation and solution
* PK profile of the single ascending doses of the IR-tablet formulation (including analysis of dose proportionality)
Conditions
- Healthy
Interventions
- DRUG
-
BI 11634 tablet
- DRUG
-
BI 11634 drinking solution
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-05-31
- Primary Completion
- 2007-07-31
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