A Study on Bioequivalence of Cabergoline Tablets in Human Body

NCT07008417 | Active Not Recruiting Phase 1

• 1 other identifier: GenSci127-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperprolactinemia

Outcome Measures

Primary Outcomes (2)

• Cmax

  : 0 hours-72 hours post-administration

• AUC0-72h

  0 hours-72 hours post-administration

Study Arms (2)

Cabergoline tablets test formulation

EXPERIMENTAL

Administration order: Cabergoline test formulation(T), Cabergoline reference formulation(R)

Drug: Cabergoline tablets test formulation

Cabergoline tablets reference formulation

EXPERIMENTAL

Administration order: Cabergoline reference formulation(R), Cabergoline test formulation(T)

Drug: Cabergoline tablets reference formulation

Interventions

Cabergoline tablets test formulation DRUG

Single oral administration

Cabergoline tablets test formulation

Cabergoline tablets reference formulation DRUG

Single oral administration

Cabergoline tablets reference formulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, 200233, China

Location

MeSH Terms

Conditions

Hyperprolactinemia

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: June 30, 2025
• Primary Completion: February 3, 2026
• Study Completion: May 6, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-10

Locations

CN (1)