Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Condi… (NCT00652704) | Clinical Trial Compass
CompletedPhase 1
Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions
Canada24 participantsStarted 1999-07
Plain-language summary
To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
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:
* Subjects will be males, non-smokers
* Between 18 and 55 years of age
* Subjects weight will be within 15% of their ideal body weight, based on 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 anormalities found during medical screening
* Any clinically significant history of ongoing problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs of drugs
* Clinically significant illnesses within 4 weeks of the administration of study medication
* Abnormal laboratory tests judged clinically significant
* ECG or vital sign abnormalities (clinically significant)
* History of allergic reactions to heparin
* Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical subinvestigator, contraindicates the subject's participation in the study
* History of severe allergies or hay fever
* Active asthma or bronchospasm
* Positive urine drug screen at screening
* Positive testing for hepatitis B, hepatitis C or HIV at screening
* Use of investigational drug or participation in an investigational study, within 30 days prior to administration of the study medication
* Recent donation of plasma (500 mL…