ClinicalTrials.gg
Active, not recruitingNCT07008417Updated Nov 17, 2025

A Study on Bioequivalence of Cabergoline Tablets in Human Body

A Phase 1 interventional study of Cabergoline tablets test formulation and Cabergoline tablets reference formulation in Hyperprolactinemia, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperprolactinemia

Browse trials for

03

In context

Hyperprolactinemia

39 studies on the registry are indexed under Hyperprolactinemia; 4 are open to participants now.

This study's enrollment of 72 is above the median of 60 across 20 interventional studies indexed under Hyperprolactinemia.

Browse Hyperprolactinemia studies →

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 111 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy subjects aged 18-45 years (including boundary values), male or female;
  • : 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-, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.

Exclusion criteria

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 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;
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Cabergoline tablets test formulation

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

    Drug: Cabergoline tablets test formulation

  • Experimental
    Cabergoline tablets reference formulation

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

    Drug: Cabergoline tablets reference formulation

Interventions

  • DrugCabergoline tablets test formulation

    Single oral administration

  • DrugCabergoline tablets reference formulation

    Single oral administration

06

What researchers measure

Primary outcomes

  1. Cmax

    Time frame: : 0 hours-72 hours post-administration

  2. AUC0-72h

    Time frame: 0 hours-72 hours post-administration

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07008417
Responsible party
Sponsor
First posted
Jun 6, 2025
Start date
Jun 30, 2025
Primary completion
Feb 3, 2026 (estimated)
Completion
May 6, 2026 (estimated)
Last update
Nov 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion