Unique ID issued by UMIN | UMIN000011518 |
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Receipt number | R000013465 |
Scientific Title | Evaluation of the drug interaction between magnesium oxide and levofloxacin |
Date of disclosure of the study information | 2013/08/19 |
Last modified on | 2013/08/19 20:05:52 |
Evaluation of the drug interaction between magnesium oxide and levofloxacin
Interaction of magnesium oxide and levofloxacin
Evaluation of the drug interaction between magnesium oxide and levofloxacin
Interaction of magnesium oxide and levofloxacin
Japan |
Patients who decided prophylactic administration of levofloxacin is necessary
Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Breast surgery | Obstetrics and Gynecology | Oto-rhino-laryngology |
Urology | Oral surgery |
Malignancy
NO
To investigate the interaction between levofloxacin and magnesium oxide in feeding condition
Pharmacokinetics
area under the blood concentration-time curve (AUC)
Interventional
Parallel
Non-randomized
Open -no one is blinded
No treatment
2
Treatment
Medicine |
administration of levofloxacin alone
co-administration of levofloxacin and magnesium oxide
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Patients receiving levofloxacin for prevention of bacterial infections
2) Signed informed consent
3) Age >= 20 and < 75 years
4) ECOG performance status: 0-3
5) Sufficient organ function of important organs
Laboratory test results meet the following criteria (within 2 weeks before registration)
a) Hemoglobin: >= 8.0 g/dL
b) WBC: >= 3,000/mm3, <12,000/mm3
c) Neutrophil: >= 1,200/mm3
d) Platelet: >= 100,000/mm3
e) ALT, AST: =< 2.5 x the ULN for the reference lab
f) Total bilirubin: =< 3 x the ULN for the reference lab
g) Creatinine: =< the ULN for the reference lab
1) Patients with a known allergy or hypersensitivity to any component of levofloxacin.
2) Patient who is unable to comply with dietary restriction*.
*Patients taking prohibited medications and supplements high in metallic cations (e.g. sucralfate, iron pill, milk, yogurt, etc.)
3) Patients who have donated over 200 ml of blood within 2 weeks of therapy.
4) Female patients who are pregnant or breast feeding and women suspected of being pregnant.
5) Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of levofloxacin (e.g. ulcerative disease, malabsorption syndrome or small bowel resection).
6) Participation in a clinical trial within 12 weeks before registration.
7) Patients deemed ineligible by the attending physicians for various reasons.
26
1st name | |
Middle name | |
Last name | Yukiyoshi Fujita |
Gunma Prefectural Cancer Center
Department of Pharmacy
617-1 Takahayashinishi-cho, Ota, Gunma
0276-38-0771
1st name | |
Middle name | |
Last name | Yukiyoshi Fujita |
Gunma Prefectural Cancer Center
Department of Pharmacy
617-1 Takahayashinishi-cho, Ota, Gunma
0276-38-0771
Department of Pharmacy, Gunma Prefectural Cancer Center
Gunma Prefecture
Local Government
Japan
NO
群馬県立がんセンター(群馬県)
2013 | Year | 08 | Month | 19 | Day |
Unpublished
Open public recruiting
2013 | Year | 03 | Month | 15 | Day |
2013 | Year | 05 | Month | 01 | Day |
2013 | Year | 08 | Month | 19 | Day |
2013 | Year | 08 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013465
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