Generic Parkinson's drug shows promise in healthy volunteer study
NCT ID NCT07519278
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a chewable postbiotic tablet keep plaque and gum inflammation at bay?
- Can a new oral drug safely help older adults manage weight?
- Can a protein powder with creatine and fiber boost everyday Well-Being?
- Green tech or hidden stress? bus Drivers' hearts monitored behind the wheel
- Shout it out: can growls and screams raise pain tolerance?
- Scientists probe why brain stimulation works for some and not others