Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2020
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.
Epistemonikos ID: 45d43b41761d0673318012afcb087e7472f28b87
First added on: May 07, 2024