NCT07008417Active, not recruitingPhase 1
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
Changchun GeneScience Pharmaceutical Co., Ltd.0 sites72 target enrollmentStarted: June 30, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 72
- Primary Endpoint
- Cmax
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
Arms & Interventions
Cabergoline tablets test formulation
Experimental
Administration order: Cabergoline test formulation(T), Cabergoline reference formulation(R)
Intervention: Cabergoline tablets test formulation (Drug)
Cabergoline tablets reference formulation
Experimental
Administration order: Cabergoline reference formulation(R), Cabergoline test formulation(T)
Intervention: Cabergoline tablets reference formulation (Drug)
Outcomes
Primary Outcomes
Cmax
Time Frame: : 0 hours-72 hours post-administration
AUC0-72h
Time Frame: 0 hours-72 hours post-administration
Secondary Outcomes
No secondary outcomes reported
Investigators
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