NCT04275492

Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

In this study, a single-center, randomized, open, two-cycle, self-crossover, single-dose administration design was used to evaluate the bioequivalence of the tested preparations and reference preparations given to Chinese healthy subjects with single-dose, fasting and post-meal administration of Pramipexole Dihydrochloride Sustained Release Tablets. This study was divided into two parts: fasting administration and high-fat post-meal administration.The healthy subjects were randomly divided into two groups with the same number of patients in each group. The washing period was 7±1 days. In this study, venous blood was collected at 18 time points (fasting and postprandial) within 1h (0h) before administration and at 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 9.0h, 10.0h, 11.0h, 12.0h, 16.0h, 36.0h, 48.0h, and 72.0h after administration. A total of 60 healthy subjects were enrolled into the equivalence test, among which: 1. Study on human bioequivalence of drug administration on an empty stomach: 30 healthy subjects (male and female). 2. Human bioequivalence of high-fat post-meal administration: 30 healthy subjects (male and female).

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride)	Praxol hydrochloride sustained release tablets, 0.375mg/ tablet, are manufactured by hongguanbio pharmaceutical co., LTD
DRUG	Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)	Siforl® is produced by Boehringer Ingelheim International Gmbh

Timeline

• Start date: 2020-07-24
• Primary completion: 2020-10-01
• Completion: 2020-12-01
• First posted: 2020-02-19
• Last updated: 2023-03-31

Locations

1 site across 1 country: China