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Active, not recruiting Phase 1

A Study on Bioequivalence of Cabergoline Tablets in Human Body

NCT07008417 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2025-06-30
Last updated
2025-11-17

Condition(s) studied

Hyperprolactinemia

Investigational drug(s) / intervention(s)

Cabergoline tablets test formulationCabergoline tablets reference formulation

Cabergoline tablets test formulation: Single oral administration

Cabergoline tablets reference formulation: Single oral administration

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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;

Primary outcome measure(s)

  • Cmax — : 0 hours-72 hours post-administration
  • AUC0-72h — 0 hours-72 hours post-administration

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Xiaoshan Hospital Hangzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07008417 on ClinicalTrials.gov ↗ ← All trials in China