Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions (NCT01380496) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions
Canada24 participantsStarted 1999-11
Plain-language summary
The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate 100 mg.
Who can participate
Age range18 Years – 55 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males, non-smokers, between 18-55 years of age
* Subjects' weight will be within 15% of their ideal weight based on the Table of "Desirable Weight of Adults", Metropolitan Life Insurance Company, 1983.
* Subjects should read, sign, and date an Informed Consent Form prior to any study procedures
* Subjects must complete all screening procedures within 28 days prior to the administration of the study medication.
Exclusion Criteria:
* Clinically significant abnormalities found during medical screening
* Any clinically significant history of ongoing gastrointestinal problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. chronic diarrhea, inflammatory bowel diseases).
* Clinically significant illnesses within 4 weeks of the administration of study medication.
* Abnormal laboratory test judged clinically significant.
* ECG or vital signs abnormalities (clinically significant).
* History of allergic reactions to doxycycline or other related drugs (e.g., chlortetracycline, demeclocycline, minocycline and tetracycline).
* History of allergic reactions to heparin.
* Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
* Positive urine drug screen (see section VIII) at screening
* Positive testing for hepatitis B, hepatitis C or HIV screening.
* Use of an investigational drug or par…