Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions (NCT00652873) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions
Canada24 participantsStarted 2001-07
Plain-language summary
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
Who can participate
Age range18 Years
SexALL
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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 females or males, smokers or non-smokers
* 18 years of age and older
* 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:
* Breast feeding female subjects
* Clinically significant anormalities found during medical screening
* Any clinically significant gastrointestinal pathology or unresolved gastrointestinal symptoms susceptible of interfering with the absorption of drugs
* Clinically significant illnesses within 4 weeks of the administration of study medication
* Abnormal laboratory tests judged clinically significant
* ECG abnormalities or vital sign abnormalities at screening
* Subjects with BMI greater than or equal to 30.0
* History of allergic reactions to cabergoline or ergot derivatives
* Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical subinvestigator, contraindicates the subject's participation in the study
* Positive urine drug screen at screening
* Positive testing for hepatitis B, hepatitis C or HIV at screening
* Positive urine pregnancy test at screening (performed on all females)
* Use of investigational drug or participation in an investigational study, within 30 days prior to administration of the study medication
* Donation of plasma (500 mL) within 7 days or donation or significant loss of …