Loading clinical trials...

TERMINATEDNA

Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets

NCT04275492•First Affiliated Hospital of Zhejiang University

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).

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects are fully aware of the purpose, nature, methods, and possible adverse effects of the test, volunteer as a subject, and sign the informed consent form before the start of any research program, and ensure that any program will be involved in the study;
•Male and female subjects aged 18-45 years (including 18 and 45 years)；
•Male body weight ≥50.0 kg, female body weight ≥45.0 kg;Body mass index \[BMI= weight (kg)/ height (m)2\] is within the range of 19.0\~26.0 kg/m2 (including critical value)；
•According to the previous medical history, vital signs, comprehensive physical examination and required laboratory examination, the investigator determines that the patient is a healthy subject;
•Fully understand the purpose of the test, the nature of the test, the research procedures and possible adverse reactions, voluntarily participate in the test and sign the informed consent (the process of obtaining the informed consent conforms to the GCP regulations);
•The subject will be able to communicate well with the investigator, understand and comply with the requirements of this study, and be willing to be admitted to the phase I clinical research ward as required.

Exclusion Criteria

•Have a history of allergy to this drug component or similar species;Had a history of allergy to two or more drugs, food, etc.;
•Have a history of dysphagia or any gastrointestinal diseases that affect drug absorption;
•Patients with any history of clinically serious diseases, including but not limited to diseases of digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system and metabolic abnormalities, which are clinically significant as judged by the investigator;
•Those who cannot tolerate venipuncture and have a history of acupuncture and blood sickness;
•Those who have received surgery (except appendicitis) within 3 months before screening, or who plan to have surgery during the study, and those who have received surgery that will affect drug absorption, distribution, metabolism and excretion;
•Screening those who had a history of drug abuse within the previous 6 months;
•Used drugs within 3 months before screening;
•Have participated in clinical trials of other drugs within 3 months before administration;
•Screening for blood donation within the first 3 months, including ingredient blood or massive blood loss (≥200mL), who received blood transfusion or used blood products;
•Have used any prescription drugs, non-prescription drugs, Chinese herbal medicine and vitamins within 2 weeks before administration;
+9 more criteria

Locations (1)

The First Affiliated Hospital,ZheJiang Univercity

Hanzhou, Zhejiang, China

Key Dates

Start Date

July 24, 2020

Primary Completion Date

October 1, 2020

Completion Date

December 1, 2020

Last Updated

March 31, 2023

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride)

DRUG

Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)

DRUG

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

View study

RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 31, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations