HyperprolactinemiaPhase 1NCT07008417
A Study on Bioequivalence of Cabergoline Tablets in Human Body
A Phase 1 study testing Cabergoline tablets test formulation and Cabergoline tablets reference formulation in people with Hyperprolactinemia, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperprolactinemia
- What is being tested?
- Cabergoline tablets test formulation and Cabergoline tablets reference formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 6 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Cabergoline tablets test formulation, Cabergoline tablets reference formulation
- Medical subject headings
- Hyperprolactinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabergoline tablets test formulationDrug
Single oral administration
Cabergoline tablets reference formulationDrug
Single oral administration
| Study group | Role | What they receive |
|---|---|---|
| Cabergoline tablets test formulation | Experimental | Administration order: Cabergoline test formulation(T), Cabergoline reference formulation(R) Receives: Drug: Cabergoline tablets test formulation |
| Cabergoline tablets reference formulation | Experimental | Administration order: Cabergoline reference formulation(R), Cabergoline test formulation(T) Receives: Drug: Cabergoline tablets reference formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: : 0 hours-72 hours post-administration
AUC0-72h
Measured: 0 hours-72 hours post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start30 Jun 2025
- Primary completion3 Feb 2026 (estimated)
- Study completion6 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperprolactinemiaStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008417
- Sponsor's protocol ID
- GenSci127-101
- Status last verified
- Oct 2025
- First submitted
- 29 May 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07008417
- Acronym / sponsor ID
- GenSci127-101
- Conditions
- Hyperprolactinemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 3 Feb 2026 (estimated)
- Study completion
- 6 May 2026 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cabergoline tablets test formulation | Experimental | Drug: Cabergoline tablets test formulationAdministration order: Cabergoline test formulation(T), Cabergoline reference formulation(R) |
| Cabergoline tablets reference formulation | Experimental | Drug: Cabergoline tablets reference formulationAdministration order: Cabergoline reference formulation(R), Cabergoline test formulation(T) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabergoline tablets test formulationSingle oral administration | Drug | Cabergoline tablets test formulation |
| Cabergoline tablets reference formulationSingle oral administration | Drug | Cabergoline tablets reference formulation |
Primary outcome
Cmax
Time frame: : 0 hours-72 hours post-administration
AUC0-72h
Time frame: 0 hours-72 hours post-administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
Related trials for Hyperprolactinemia
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Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Prolactinoma, Prolactin Excess
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Carbergoline for Antipsychotic Induced Hyperprolactinemia.
Scizophrenia
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A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets
Hyperprolactinemia
RecruitingPhase 4
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Prolactinoma
Not yet recruitingObservational study
Impact of Helicobacter Pylori Infection on Prolactin Levels in Reproductive-Age Women to Determine Whether H. Pylori Infection is Associated with Elevated Prolactin Levels and Assess the Clinical Implications
HELICOBACTER PYLORI INFECTIONS, Hyperprolactinaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cabergoline tablets test formulation and Cabergoline tablets reference formulation in people with Hyperprolactinemia, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: : 0 hours-72 hours post-administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.