A Study on Bioequivalence of Cabergoline Tablets in Human Body

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called cabergoline, which is used to treat a condition known as hyperprolactinemia, where the body produces too much of a hormone called prolactin. The goal of the study is to compare two different versions of cabergoline tablets to see if they work the same way in healthy people. The trial will take place in healthy Chinese adults, both before and after eating, to understand how food affects the drug's effectiveness.

To participate in this study, individuals must be healthy adults aged 18 to 45 years, with a normal weight range. They should not have any serious health issues or a history of allergies to cabergoline or other medications. Participants will undergo a series of health checks to ensure they are suitable for the study. Since the trial is not yet recruiting, it means that people cannot sign up just yet, but it’s important to know that those who do participate can expect to contribute to important research that may help others with similar health conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy subjects aged 18-45 years (including boundary values), male or female;
• • Body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg;
• • Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.
• Exclusion Criteria:
• • Received camergoline treatment within the past six months; Those who have a history of allergy to carergoline or any drug component; Those who have had a history of allergy to two or more drugs, foods, etc.
• • Those who currently have the following clinically significant diseases, including but not limited to peripheral vascular lesions, orthostatic hypotension, valvular heart disease, fibrous lesions, severe peptic ulcers and other diseases, or have a previous history of related diseases; Or those with other related diseases of the respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, mental and nervous system, otorhinolaryngology, etc., which have been judged by researchers as having clinical significance;