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Pharmacokinetic study of linezolid in high and low weight group healthy male volunteers

Pharmacokinetic study of linezolid in high and low weight group healthy male volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-RNC-10001174
Enrollment
Unknown
Registered
2010-12-15
Start date
2011-01-05
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infection

Interventions

1:I.V. linezolid according to body weight, 10mg/Kg

Sponsors

Ministry of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. fully understand the content of trial and possible adverse reactions. Be voluntary to participate in this clinical trial and sigh the written informed consent form; 2. men, healthy, 18~45 years old; 3. low weight group between 50kg and 55kg, high weight group more than 80kg; 4. No heart, liver, kidney, gastrointestinal tract, nervous system, metabolic disorders and other medical history; 5. no drug and food allergies, no tobacco and alcohol addiction; 6. at least 4 weeks without taking any other drugs; 7. through medical history taking, physical examination, vital signs, clinical laboratory tests, chest X-ray examination, 12 lead ectrocardiogram confirmed health; 8. has probable compliance and very likely to complete the study.

Exclusion criteria

Exclusion criteria: 1. through medical history taking, physical examination and laboratory tests, prove that subjects suffering from any disease and tuberculosis, family history, a history of past or current history; after the review of laboratory data and comprehensive physical examination, find that Subjects have clinically significant abnormalities; 2. systolic blood pressure lower than 90 mm Hg or higher 140 mm Hg. diastolic blood pressure higher than 90 mm Hg; 3. suffer from anemia or other blood diseases, bleeding disorders, not healed trauma; 4. have a personal or family history of autoimmune disease or a history of allergies; 5. directly involved in the study of the clinical trials unit and their families; 6. have blood donation within one month before the study, or intend to do it within one month after the end of the study; 7. consume more than 28 units of alcohol (1 unit = 285ml of beer or 25ml spirits or 1 glass of wine) weekly; smoke more than five cigarettes per day (or the same amount of tobacco); drink alcoholic beverages within 48 hours before Study Day 1; 8. receive study drug within 3 months before screening period; be using or used any prescription or buy their own drugs (including corticosteroids, etc.) within 4 weeks before receiving study drug; 9. for any reason, researchers deem that the subject can not complete the study.

Design outcomes

Primary

MeasureTime frame
Vd;CL;Tmax;AUC;Ka;Ke;t1/2;Cmax;

Countries

China

Contacts

Public ContactYun Cai
caicaihh@sohu.com+86 010 66937908

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026