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 range
18 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.