Trial Profile
A Study to Assess the Bioavailability and Pharmacokinetics of an Immediate Release Tablet Formulation of Lefamulin When Administered to Fed and Fasted Healthy Subjects in Comparison to an Intravenous Formulation and a Capsule Formulation
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 12 Apr 2019
Price :
$35
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At a glance
- Drugs Lefamulin (Primary) ; Lefamulin (Primary) ; Lefamulin (Primary)
- Indications Bacterial infections; Bone and joint infections; Community-acquired pneumonia; Nosocomial pneumonia; Osteomyelitis; Sexually transmitted infections; Skin and soft tissue infections
- Focus Pharmacokinetics
- Sponsors Nabriva Therapeutics
- 01 Apr 2019 Results assessing the pharmacokinetics and tolerability of lefamulin following intravenous and oral dosing in four studies (NCT01119105, NCT02557789, EudraCT2012-004404-35 and EudraCT2012-000025-50) published in the Journal of Antimicrobial Chemotherapy
- 01 Apr 2019 Results of population PK model to predict the ELF penetration ratio of lefamulin after IV or oral administration in the fed and fasted state using data from NAB-BC3781-1107 and NAB-BC3781-1005 studies, published in the Journal of Antimicrobial Chemotherapy
- 25 Apr 2017 Results presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases