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An open-label prospective study for the penetration of nemonoxacin into human bronchopulmonary tissues and fluids following multiple oral doses in patients undergoing pulmonary lobectomy

An open-label prospective study for the penetration of nemonoxacin into human bronchopulmonary tissues and fluids following multiple oral doses in patients undergoing pulmonary lobectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022591
Enrollment
Unknown
Registered
2019-04-17
Start date
2019-04-18
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

Community acquired pneumonia

Interventions

Group 1:Sampling 2 hours after administration on the surgery day
Group 2:Sampling 5 hours after administration on the surgery day
Group 3:Sampling 9 hours after administration on the surgery day
Group 4:Sampling 12hours after administration on the surgery day
Group 5:Sampling 24 hours after administration on the surgery day

Sponsors

Huashan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Before the study begin,we should get the informed consent file from ethics committee by the patient or his legal representative; 2. Male or female aged 18 to 75 years; 3. BMI between 19~26kg/m2; 4. The patients who were diagnosed as lung cancer and will undergo pulmonary lobectomy (including single or multiple lobes or pneumonectomy) and meet the surgical criteria.

Exclusion criteria

Exclusion criteria: 1. Patients who can not meet to the surgical criteria for lobectomy; 2. Patients with moderate or severe renal dysfunction, which means endogenous creatinine clearance rate <50mL/min; endogenous creatinine clearance rate(male)=(140-age) ×body weight(kg)/SCr(mg/dl) × 72 endogenous creatinine clearance rate(female)= endogenous creatinine clearance rate(male)× 0.85; 3. Abnormal liver function test: Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) is greater than 3 times the upper limit of reference within 48 hours before enrollment, and total bilirubin or direct bilirubin is greater than 1.5 times the upper limit of the reference value within 48 hours before enrollment; 4. Patients who are known or suspected to be allergic to drugs such as quinolones or those who are allergic sufferer; 5. Patients who have seizures or acute central nervous system diseases, or mental disorders that may affect protocol compliance, or suicide risk, or alcohol or illicit drug abuse history; 6. Patients who have severely immune system dysfunction, such as HIV infection; or advanced blood system cancer; or splenectomy; 7. Patients who have dysfunction syndrome or other gastrointestinal diseases that affect drug absorption; 8. Patients who taking quinolones for treatment within one week before enrollment; 9. Pregnant patients (positive blood pregnancy test), or lactating patients; 10. The investigator consider that there may be any situation that increases the risk of the subject or interferes with clinical research; 11. Patients who have participated in this clinical study and have taken the study drug before enrollment.

Design outcomes

Primary

MeasureTime frame
Ratio of drug concentration and AUC in bronchopulmonary body fluid to plasma at the same time;

Countries

China

Contacts

Public ContactRen Li

Zhejiang Medicine Co., Ltd Xinchang Pharmaceutical Factory

ren18602658073@qq.com+86 18602658073

Outcome results

None listed

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