Status:
COMPLETED
Effect of Ceftobiprole on Human Intestinal Microflora
Lead Sponsor:
Basilea Pharmaceutica
Conditions:
Antimicrobial Agent
Cephalosporins
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal microflora in healthy volunteers.
Detailed Description
This is an open-label, single center study to investigate the effect on human intestinal microflora of multiple doses of ceftobiprole treatment administered at 8 hours intervals for 7 consecutive days...
Eligibility Criteria
Inclusion
- \- Healthy volunteers with body weight \>= 50 kg and body mass index between 18 and 30
- Agree to remain hospitalized at the trial unit during the 7-day drug administration period and will only leave the trial unit under supervision of a study nurse twice a day for one hour maximum
- Refrain from excessive jogging and any strenuous exercise during the study
- Be able to adhere to the dietary, fluid and smoking restrictions during the study
- Have negative pregnancy test result at the screening and agree to use adequate contraception method and not to become pregnant or donate sperm throughout the study
Exclusion
- No clinically significant medical illness, abnormal findings in physical examination, vital signs, laboratory tests and electrocardiogram, or known allergy to the study drug, cephalosporins, beta-lactam antibiotics or other clinically significant allergies requiring treatment
- No antibiotic treatment within the last 3 months
- No drug or alcohol abuse within the last 5 years
- No blood donation or substantial loss of blood of more than 500 ml within the last 3 months or intention to donate blood during the study or within 1 month after study completion
- No history of smoking of more than 10 cigarettes , or 2 cigars, or 2 pipes of tobacco or 5 sniffs per day within the last 3 months
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00965042
Start Date
April 1 2009
End Date
June 1 2009
Last Update
July 30 2012
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