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Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets (PLKS-BE)
The main purpose of In two kinds of fasting and postprandial Chinese healthy subjects with Boehringer represent Ingelheim company production of hydrochloric acid Pramipexole zyban (specification: 0.26 mg/piece, in Pramipexole, commodity name: Siforl ®) as the reference preparation, study a single oral dose of macro crown biological pharmaceutical co., LTD. Production of Pramipexole Dihydrochloride Sustained Release Tablets (specification:The pharmacokinetic parameters of the drug were calculated after the time course of the drug in vivo (0.375mg/ tablet, as measured by pramipexole hydrochloride), and the human relative bioavailability of the two preparations were compared to evaluate their bioequivalence. A secondary purpose To evaluate the safety of fasting and postprandial oral test preparations and reference preparations.
Details
| Lead sponsor | First Affiliated Hospital of Zhejiang University |
|---|---|
| Phase | NA |
| Status | TERMINATED |
| Enrolment | 30 |
| Start date | Fri Jul 24 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Dec 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Parkinson's Disease
Interventions
- Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride)
- Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)
Countries
China