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Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets

NCT04275492 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-31

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hongguan biological pharmaceutical co.

    collaborator UNKNOWN

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Jian Liu, Master · The First Affiliated Hospital,ZheJiang Univercity

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2020-10-01
Completion
2020-12-01

Countries

  • China

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04275492 on ClinicalTrials.gov