Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
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.