A Study on Bioequivalence of Cabergoline Tablets in Human Body

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-05-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperprolactinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cabergoline tablets test formulation

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

Group Type EXPERIMENTAL

Cabergoline tablets test formulation

Intervention Type DRUG

Single oral administration

Cabergoline tablets reference formulation

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

Group Type EXPERIMENTAL

Cabergoline tablets reference formulation

Intervention Type DRUG

Single oral administration

Interventions

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Cabergoline tablets test formulation

Single oral administration

Intervention Type DRUG

Cabergoline tablets reference formulation

Single oral administration

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes