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The study compared pramipexole dihydrochloride extended-release tablets (Test formulation) by Haisco Pharmaceutical Group Co., Ltd. with the reference formulation (MIRAPEX ER®,Boehringer Ingelheim GmbH of Germany) to evaluate the bioequivalence of single dose in Chinese healthy subjects under fasting and fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test formulation | Experimental | pramipexole dihydrochloride extended-release tablets (0.375 mg/table),Manufacturer: Haisco Pharmaceutical Group Co., Ltd |
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| Reference formulation | Experimental | pramipexole dihydrochloride extended-release tablets (MIRAPEX ER®,0.375 mg/table) Manufacturer: Boehringer Ingelheim GmbH of Germany |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test formulation(pramipexole dihydrochloride extended-release tablets) | Drug | Test formulation (pramipexole dihydrochloride extended-release tablets, Haisco Pharmaceutical Group Co., Ltd), A single oral dose of 0.375 mg, taken with 240mL of water |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum Concentration) | The pharmacokinetic parameters of pramipexole in plasma | From the start of administration to 72 hours post-dose |
| AUC(0-t) (Area Under the Concentration-Time Curve from time 0 to time t) | The pharmacokinetic parameters of pramipexole in plasma | From the start of administration to 72 hours post-dose |
| AUC(0-∞) (Area Under the Concentration-Time Curve from time 0 to infinity) | The pharmacokinetic parameters of pramipexole in plasma | From the start of administration to 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AEs (Adverse Events) | The incidence and severity of AEs | From the time of signing ICF (Informed Consent Form) to the end of follow-up,up to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with serious systemic diseases, infectious diseases, or mental disorders that, in the investigator's opinion, make them unsuitable for participation in this study;
History of clinically significant ECG abnormalities or family history of long QT syndrome (grandparents, parents, and siblings);
Known or suspected history of allergy to the investigational drug or drugs with a similar chemical structure;
Presence of conditions that may affect drug absorption, distribution, metabolism, or excretion, including but not limited to any of the following:
Subjects with positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or syphilis antibody;
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);
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;
Blood donation or blood loss of ≥ 400 mL within 3 months prior to screening;
Participation in another clinical trial within 3 months prior to screening;
Use of any prescription medication within 4 weeks prior to screening;
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;
Pregnant or breastfeeding women;
History of orthostatic hypotension, sudden vertigo, or transient syncope;
Subjects deemed unsuitable for participation in the study by the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of Western Theater Command PLA | Chengdu | Sichuan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42116205 | Derived | Chen Q, Shi HQ, Chen YF, Zhang W, Ye L, Li YM, Hu TT. Comparative pharmacokinetics for bioequivalence of pramipexole dihydrochloride extended-release tablets in fasting and fed Chinese healthy volunteers: a randomized, open-label, single-dose, crossover study. BMC Pharmacol Toxicol. 2026 May 11;27(1):94. doi: 10.1186/s40360-026-01144-w. |
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| Reference formulation(MIRAPEX ER®) | Drug | Reference formulation (pramipexole dihydrochloride extended-release tablets, Boehringer Ingelheim GmbH of Germany), A single oral dose of 0.375 mg, taken with 240mL of water |
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