NCT07008417

A Study on Bioequivalence of Cabergoline Tablets in Human Body

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Cabergoline tablets test formulation	Single oral administration
DRUG	Cabergoline tablets reference formulation	Single oral administration

Timeline

• Start date: 2025-06-30
• Primary completion: 2026-02-03
• Completion: 2026-05-06
• First posted: 2025-06-06
• Last updated: 2025-11-17

Locations

1 site across 1 country: China