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NCT07519278
Bioequivalence Study of Pramipexole Dihydrochloride Extended-release Tablets in Healthy Chinese Subjects
Phase 1 trial testing Test formulation（pramipexole dihydrochloride extended-release tablets） in Healthy in 49 participants. Completed in 12 February 2018.
11 April 2017
Quick facts
| Lead sponsor | Haisco Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 49 |
| Start date | 16 March 2017 |
| Primary completion | 11 April 2017 |
| Estimated completion | 12 February 2018 |
| Sites | 1 location across China |
Drugs / interventions tested
- Test formulation（pramipexole dihydrochloride extended-release tablets）
- Reference formulation（MIRAPEX ER®）
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Haisco Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Chen Q, Shi HQ, Chen YF, Zhang W, et al · · 2026 · PMID 42116205 · DOI 10.1186/s40360-026-01144-w
Verify or expand the search:
- PubMed search for NCT07519278
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Haisco Pharmaceutical Group Co., Ltd. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07519278 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Haisco Pharmaceutical Group Co., Ltd.
- Last refreshed: 14 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07519278.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing