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Generic Parkinson's drug shows promise in healthy volunteer study

NCT ID NCT07519278

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a new generic version of pramipexole extended-release tablets works the same as the brand-name drug (MIRAPEX ER) in 49 healthy Chinese adults. Participants took a single dose of either the generic or brand-name drug, and researchers measured drug levels in their blood to check for bioequivalence. The study also monitored for side effects. This is a Phase 1 trial, meaning it focused on safety and how the body processes the drug, not on treating a disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

49 people

The number who actually took part.

Started

Mar 2017

Finished

Feb 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy male and female subjects aged 18 years or older (inclusive); 2. Body weight ≥ 50 kg for males and ≥ 45 kg for females, with body mass index (BMI) between 19 and 26 (inclusive); 3. No clinically significant abnormalities in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), chest X-ray (posteroanterior view), or abdominal ultrasound at screening; 4. All subjects must be willing to use appropriate contraceptive measures from the screening period, throughout the trial drug administration period, and until one month after drug discontinuation; 5. Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form. Exclusion Criteria: 1. Subjects with serious systemic diseases, infectious diseases, or mental disorders that, in the investigator's opinion, make them unsuitable for participation in this study; 2. History of clinically significant ECG abnormalities or family history of long QT syndrome (grandparents, parents, and siblings); 3. Known or suspected history of allergy to the investigational drug or drugs with a similar chemical structure; 4. Presence of conditions that may affect drug absorption, distribution, metabolism, or excretion, including but not limited to any of the following: * History of inflammatory bowel disease, gastritis, gastrointestinal ulcer, gastrointestinal bleeding, or other clinically significant gastrointestinal abnormalities. * History of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, enterectomy, gastric bypass, gastric partitioning, or gastric banding). * History of clinically significant renal disease or impaired renal function, or laboratory abnormalities at screening. * Liver disease or laboratory abnormalities indicative of clinically significant hepatic impairment at screening. 5. Subjects with positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or syphilis antibody; 6. History of drug abuse or alcohol abuse within 12 months prior to screening (consuming more than 2 units of alcohol per day or more than 14 units per week; 1 unit = 355 mL beer, 30 mL liquor, or 150 mL wine); 7. Average daily smoking of more than 5 cigarettes within 3 months prior to screening (assessed by interview at screening), or inability to refrain from smoking during the entire study period; 8. Blood donation or blood loss of ≥ 400 mL within 3 months prior to screening; 9. Participation in another clinical trial within 3 months prior to screening; 10. Use of any prescription medication within 4 weeks prior to screening; 11. Use of over-the-counter drugs, health supplements, herbal medicines, or traditional Chinese medicines within 2 weeks prior to screening. Refusal to discontinue any beverages or foods containing xanthines, such as caffeine (coffee, tea, cola, chocolate, etc.), from 48 hours before dosing until the end of the study; 12. Pregnant or breastfeeding women; 13. History of orthostatic hypotension, sudden vertigo, or transient syncope; 14. Subjects deemed unsuitable for participation in the study by the investigator.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The General Hospital of Western Theater Command PLA

    Chengdu, Sichuan, China

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