A Study on Bioequivalence of Cabergoline Tablets in Human Body

GeneScience Pharmaceuticals (GenSci)

Status and phase: Active, not recruiting; Phase 1

Conditions: Hyperprolactinemia

Treatments: Drug: Cabergoline tablets test formulation; Drug: Cabergoline tablets reference formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07008417

GenSci127-101

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Cabergoline tablets test formulation

Experimental group

Description:

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

Treatment:

Drug: Cabergoline tablets test formulation

Cabergoline tablets reference formulation

Experimental group

Description:

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

Treatment:

Drug: Cabergoline tablets reference formulation