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Pharmacokinetics of Linezolid in healthy Chinese volunteers

Pharmacokinetics of Linezolid in healthy Chinese volunteers

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-10000751
Enrollment
Unknown
Registered
2010-01-10
Start date
2010-01-05
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

G+ infectious diseases

Interventions

A:600mg/30min, 600mg/120min, 600mg/240min, different time of iv
B:600mg/60min,bid, iv, 3d vs. 600mg/60min,bid, iv, 3d+600mg,op,4d

Sponsors

PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Men and women aged 18 to 45 years, of Chinese descent and living in China. They must agree and commit to use a informed consent form during the screening period, throughout the study (including follow-up). 2. Body mass index (BMI) in the range of 18.0 to 25.0 kg/m^2; 3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, chest x-ray examination, and 12-lead electrocardiogram (ECG); 4. Have a high probability for compliance with and completion of the study.

Exclusion criteria

Exclusion criteria: 1. Presence or history of any disorder that may prevent the successful completion of the study; 2. Serious infection (infection associated with hospitalization and/or parenteral antimicrobial agents) within 1 month before test article administration or active infection at screening; 3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease; 4. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day; 5. History of alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements.

Design outcomes

Primary

MeasureTime frame
concentration of drug in plasm;

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