Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers
NCT02256709 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2014-10-06
Summary
Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)
Conditions
- Healthy
Interventions
- DRUG
-
BIBP 5371 CL tablet
single rising daily doses
- DRUG
-
BIBP 5371 CL solution
- OTHER
-
High fat, high caloric breakfast
- DRUG
-
Placebo tablet
- DRUG
-
BIBP 5371 CL tablet high dose
- DRUG
-
Placebo drinking solution
- DRUG
-
BIBP 5371 CL tablet low dose
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2004-04-30
- Primary Completion
- 2004-08-31
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