Absolute bioavailability study
The objectives of Part 1 with intravenous finerenone doses including 0.25 mg, 0.5 mg and 1.0 mg infused over 1 h were to investigate the safety, tolerability and pharmacokinetics of these treatments and to select an appropriate intravenous dose for Part 2.
The primary objective of Part 2 of this study, performed in a randomized, non-blinded, non-placebo controlled 2-way crossover design in 16 healthy male subjects, was to evaluate the absolute bioavailability of a single oral dose of a 5 mg IR tablet of finerenone in comparison to an intravenous infusion of 1 mg over 1 h (iv dose as planned and confirmed by results of Part 1) and to characterize the pharmacokinetics of finerenone after intravenous administration. The secondary objectives of Part 2 were to investigate the safety and tolerability.
- Healthy male white subjects between 18 and 46 years of age (inclusive) and a body mass index ≥ 18 and ≤ 29.9 kg/m^2
No Exclusion Criteria Available
Mönchengladbach, Germany, 41061
E-mail: [email protected]
Phone: (+) 1-888-8422937
Study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of an intravenous solution of finerenone (dose escalation and group comparison, part 1) and to investigate the absolute bioavailability of an oral dose of 5 mg finerenone (BAY 94 8862) in comparison to an intravenous solution of finerenone (planned dose 1 mg) administered over 1 hour (randomized, non-blinded, non-placebo-controlled, 2-way crossover design, part 2)