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Active, Not Recruiting

NCT Number: NCT07008417

A Study on Bioequivalence of Cabergoline Tablets in Human Body

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, 200233, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Cabergoline tablets test formulation

Drug

Single oral administration

Cabergoline tablets reference formulation

Drug

Single oral administration

Primary outcomes

  1. Cmax

    Time frame: : 0 hours-72 hours post-administration

  2. AUC0-72h

    Time frame: 0 hours-72 hours post-administration

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Single-center, Randomized, Open-label, Two-formulation, Two-cycle, Two-sequence, Single-dose, Crossover Bioequivalence Study of Cabergoline Tablets Under Fasting and Postprandial Conditions in Healthy Chinese Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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