Trial Condition(s):
Diabetic Kidney Disease
Pilot bioavailability study with finerenone
Bayer Identifier:
19092
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The primary objective of the study was to
• investigate the relative bioavailability of 20 mg finerenone tablet manufactured in a continuous process (ConsiGma) in comparison to 20 mg finerenone tablet manufactured in a batch process (i.e. the current Phase 3 formulation) in the fasting condition
The secondary objective of this study was to
• investigate the safety and tolerability of single oral doses of finerenone
Inclusion Criteria
- Healthy male white subjects, 18 to 45 years of age (inclusive), Body mass index (BMI): ≥ 18.0 and ≤ 29.9 kg/m²
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations CRS Clinical-Research-Services Mönchengladbach GmbH Mönchengladbach, Germany, 41061 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Single dose, open-label, randomized, two-fold crossover study in healthy male subjects to investigate the bioavailability of 20 mg finerenone immediate-release tablets manufactured in a continuous process (ConsiGma) in comparison to tablets manufactured in a batch process (current Phase 3 formulation)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Maximum observed concentration (Cmax) after single dose administration of finerenoneTimeframe: From pre-dose up to 24 hours after drug administration in each treatment period
- Area under concentration versus time curve from zero to infinity (AUC) after single dose administration of finerenoneTimeframe: From pre-dose up to 24 hours after drug administration in each treatment period
Secondary Outcome
- Number of participants with adverse eventsTimeframe: From first application of study medication up to 3 days after last study drug
Additional Information
Not Available
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