Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy male or female subjects - as determined by the investigator or medically qualified designee based on medical evaluations, including medical history, physical examination, laboratory tests and cardiac monitoring
Aged 18 to 45 years at the first screening visit
Body Mass Index (BMI) of 18.0 - 34 kg / m\*2 , with body weight ≥ 50 kg
Creatinine clearance ≥ 90 mL/min using the Modification of Diet in Renal Disease
Adequate end organ and bone marrow function
You may not be if
Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus)
Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
Relevant respiratory insufficiency / disorder
Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing
Known history of hypersensitivity (or known allergic reaction) to copanlisib, metformin, related compounds, or any components of the formulation
Clareo Health | Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics
