Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults
NCT02342418 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2017-03-15
Summary
This is an open label, single-dose, pharmacokinetic study in 9 obese and 9 age-, sex-, ideal body weight- matched non-obese subjects. Qualifying subjects who have completed an informed consent will receive a single intravenous dose of tedizolid with the collection of 11 blood samples over 72 hours post dose.
Conditions
Interventions
- DRUG
-
Tedizolid phosphate
Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Amit.Pai
lead OTHER
Principal Investigators
-
Manjunath Pai, PharmD · University of Michigan
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-03-31
- Primary Completion
- 2015-09-30
- Completion
- 2015-12-31
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