PMID- 29899212
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220409
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 7
IP  - 6
DP  - 2018 Jun 14
TI  - Pharmacokinetics of Tedizolid and Pseudoephedrine Administered Alone or in 
      Combination in Healthy Volunteers.
LID - 10.3390/jcm7060150 [doi]
LID - 150
AB  - Therapeutic doses of tedizolid phosphate, an oxazolidinone antibiotic, lack 
      monoamine oxidase inhibition in vivo, potentially resulting in an improved safety 
      profile versus other oxazolidinones. This randomized, double-blind, 
      placebo-controlled, 2-period, 2-sequence, crossover, phase 1 study (NCT01577459) 
      assessed the potential for pharmacokinetic (PK) interactions between tedizolid 
      and pseudoephedrine. Eighteen healthy volunteers (age: 18(-)45 years) were 
      block-randomized to 1 of 2 treatment sequences containing 2 treatment periods 
      (tedizolid phosphate or placebo once daily for 4 days; single dose of 
      pseudoephedrine 60 mg on day 5) separated by a 2-day washout. Median time to 
      maximum plasma concentration for tedizolid and pseudoephedrine ranged from 3 to 4 
      h, regardless of treatment coadministration. Steady-state tedizolid had no effect 
      on the PK of pseudoephedrine; geometric mean ratio and 90% confidence interval 
      remained within the no-effect 0.8 to 1.25 boundaries. The maximum observed 
      concentration of tedizolid decreased by approximately 14% when pseudoephedrine 
      was coadministered; no changes in the area under the plasma concentration-time 
      curve or the minimum observed plasma concentration occurred. All adverse events 
      (AEs) were mild, and there were no serious AEs or study drug discontinuations. No 
      meaningful PK interactions occurred between tedizolid and pseudoephedrine, and 
      tedizolid was well tolerated when administered in conjunction with 
      pseudoephedrine.
FAU - Flanagan, Shawn
AU  - Flanagan S
AD  - Merck & Co., Inc., Kenilworth, NJ 07033, USA. sf.in.sd@earthlink.net.
FAU - Minassian, Sonia L
AU  - Minassian SL
AD  - Minassian Biostatistics, Inc., San Diego, CA 92121, USA. sminassi@yahoo.com.
FAU - Prokocimer, Philippe
AU  - Prokocimer P
AD  - Merck & Co., Inc., Kenilworth, NJ 07033, USA. ppkprokocimer@gmail.com.
LA  - eng
PT  - Journal Article
DEP - 20180614
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC6025247
OTO - NOTNLM
OT  - acute bacterial skin infections
OT  - antibiotics
OT  - drug interactions
OT  - infectious disease
OT  - oxazolidinone
OT  - pharmacokinetics
COIS- S.F. was an employee of Merck at the time of the study. P.P. was an employee and 
      a stockholder of Merck at the time of the study. S.L.M. is a consultant to Merck 
      and was compensated for supporting this research. The authors have no other 
      funding or conflicts of interest to disclose.
EDAT- 2018/06/15 06:00
MHDA- 2018/06/15 06:01
PMCR- 2018/06/14
CRDT- 2018/06/15 06:00
PHST- 2018/06/06 00:00 [received]
PHST- 2018/06/13 00:00 [accepted]
PHST- 2018/06/15 06:00 [entrez]
PHST- 2018/06/15 06:00 [pubmed]
PHST- 2018/06/15 06:01 [medline]
PHST- 2018/06/14 00:00 [pmc-release]
AID - jcm7060150 [pii]
AID - jcm-07-00150 [pii]
AID - 10.3390/jcm7060150 [doi]
PST - epublish
SO  - J Clin Med. 2018 Jun 14;7(6):150. doi: 10.3390/jcm7060150.