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Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Relebactam, a β-Lactamase Inhibitor, in Combination with Imipenem and Cilastatin in Healthy Participants
- Source :
- Antimicrobial Agents and Chemotherapy; June 2018, Vol. 62 Issue: 9
- Publication Year :
- 2018
-
Abstract
- Relebactam is a novel class A and C β-lactamase inhibitor that is being developed in combination with imipenem-cilastatin for the treatment of serious infections with Gram-negative bacteria. Here we report on two phase 1 randomized, double-blind, placebo-controlled pharmacokinetics, safety, and tolerability studies of relebactam administered with or without imipenem-cilastatin to healthy participants: (i) a single-dose (25 to 1,150 mg) and multiple-dose (50 to 625 mg every 6 h [q6h] for 7 to 14 days) escalation study with men and (ii) a single-dose (125 mg) study with women and elderly individuals.
Details
- Language :
- English
- ISSN :
- 00664804 and 10986596
- Volume :
- 62
- Issue :
- 9
- Database :
- Supplemental Index
- Journal :
- Antimicrobial Agents and Chemotherapy
- Publication Type :
- Periodical
- Accession number :
- ejs46944950
- Full Text :
- https://doi.org/10.1128/AAC.00280-18