Bioavailability Study of Metronidazole Capsules Under Fed Conditions (NCT01380522) | Clinical Trial Compass
CompletedPhase 1
Bioavailability Study of Metronidazole Capsules Under Fed Conditions
Canada18 participantsStarted 2002-08
Plain-language summary
The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D. Searle, Inc.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Subjects meeting all the following criteria may be included in the study
* Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject.
* Males or females aged from 18 to 50 years with a body mass index (BMI) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the Case Report Forms (CRF) (laboratory tests are presented in section 7.1.3)
* Healthy according to the laboratory results and physical examination
* Subjects should be non-or ex-smokers
Exclusion Criteria:
* Significant history of hypersensitivity to metronidazole or any related products as well as sever hypersensitivity reactions (like angioedema) to any drugs.
* Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
* Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
* Females who are pregnant, lactating or are likely to becom…