Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF)Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose)in Healthy Female Subjects
NCT02438696 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2015-09-24
Summary
The primary objective is to investigate the relative bioavailability of two newly developed tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is the comparison of several pharmacokinetic parameters between the treatments.
Conditions
- Healthy
Interventions
- DRUG
-
BI 1060469, iFF, Test
- DRUG
-
BI 1060469, iFF, Test
- DRUG
-
BI 1060469, TF1, Reference
- DRUG
-
BI 1060469, TF2, Test
- DRUG
-
BI 1060469, TF2, Test
- DRUG
-
BI 1060469, iFF, Test
- DRUG
-
BI 1060469, TF1, Reference
- DRUG
-
BI 1060469, iFF, Test
- DRUG
-
BI 1060469, iFF, Test
- DRUG
-
BI 1060469, TF1, Reference
- DRUG
-
BI 1060469, TF2, Test
- DRUG
-
BI 1060469, TF1, Reference
- DRUG
-
BI 1060469, TF1, Reference
- DRUG
-
BI 1060469, TF2, Test
- DRUG
-
BI 1060469, TF2, Test
- DRUG
-
BI 1060469, iFF, Test
- DRUG
-
BI 1060469, TF2, Test
- DRUG
-
BI 1060469, TF1, Reference
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2015-08-31
- Completion
- 2015-08-31
Countries
- Germany
Study Locations
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