A Study on Bioequivalence of Cabergoline Tablets in Human Body

Not Applicable

Recruiting

• Conditions: Hyperprolactinemia
• Interventions: Drug: Cabergoline tablets test formulation; Drug: Cabergoline tablets reference formulation

• Registration Number: NCT07008417
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the bioequivalence of the test formulation and reference formulation of cabergoline tablets in healthy Chinese subjects under fasting and postprandial conditions.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-29
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-06
• Study Start: 2025-06-30
• Last Update Submitted: 2025-07-04
• Last Update Posted: 2025-07-08
• Primary Completion: 2026-02-03
• Study Completion: 2026-05-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cabergoline tablets test formulation	Cabergoline tablets test formulation	Administration order: Cabergoline test formulation(T), Cabergoline reference formulation(R)
Cabergoline tablets reference formulation	Cabergoline tablets reference formulation	Administration order: Cabergoline reference formulation(R), Cabergoline test formulation(T)

Primary Outcome Measures

Name	Time	Method
Cmax	: 0 hours-72 hours post-administration
AUC0-72h	0 hours-72 hours post-administration