Relative Bioavailability of Two Fixed Dose Combination Tablets of Linagliptin/Pioglitazone Compared With Single Linagliptin and Pioglitazone Tablets Administered Together to Healthy Male and Female Subjects
NCT02183636 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2014-07-08
Summary
Determination of the relative bioavailability of 2 different formulations of a 5 mg linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination (FDC) tablet, formulation C5 and formulation C8, compared with the mono-components linagliptin and pioglitazone administered together
Conditions
- Healthy
Interventions
- DRUG
-
Linagliptin/pioglitazone, FDC formulation C5
film coated tablet (5 mg/45 mg)
- DRUG
-
Linagliptin/pioglitazone, FDC formulation C8
film coated tablet (5 mg/45 mg)
- DRUG
-
Linagliptin tablet
5 mg
- DRUG
-
pioglitazone tablet (Actos®)
45 mg
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-08-31
- Primary Completion
- 2009-12-31
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