Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets

NCT04275492 | Terminated

• 1 other identifier: ZYYY-PLKS-BE-2019-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Parkinson's Disease

Keywords

Pramipexole Dihydrochloride Sustained Release Tablets

Outcome Measures

Primary Outcomes (4)

• Cmax

  Maximum observed plasma concentration

  [time range: 72 hours post-dose on Day 1,8]

• Tmax

  Time to maximum plasma concentration

  [time range: 72 hours post-dose on Day 1,8]

• AUC（0-inf）

  Area under a time curve of plasma concentration from time 0 to infinity

  [time range: 72 hours post-dose on Day 1,8]

• AUC（0-72h）

  Area under the concentration-time curve 0 to 72 h after administration

  [time range: 72 hours post-dose on Day 1,8]

Study Arms (2)

Fasting group

EXPERIMENTAL

Subjects were randomly assigned to one of two sequential groups (t-r group, r-t group) in a 1:1 ratio.In the first cycle, 15 subjects were given 1 tablet of test preparation (T) orally and 240mL warm water on an empty stomach, and the other 15 subjects were given 1 tablet of reference preparation (R, Siforl®) orally and 240mL warm water on an empty stomach.Cross-administration at 7±1 days.The authorized drug dispenser assigned the study drug to each phase of the study according to a randomized protocol.

Drug: 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)

Feeding group

EXPERIMENTAL

Subjects were randomly assigned to one of two sequential groups (t-r group, r-t group) in a 1:1 ratio.In the first cycle, 15 subjects took 1 tablet of the test preparation (T) orally and 240mL warm water about 30min after the high-fat meal, and another 15 subjects took 1 tablet of the reference preparation (R, Siforl®) orally and 240mL warm water about 30min after the high-fat meal.Cross-administration at 7±1 days.The authorized drug dispenser assigned the study drug to each phase of the study according to a randomized protocol.

Drug: 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)

Interventions

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

Praxol hydrochloride sustained release tablets, 0.375mg/ tablet, are manufactured by hongguanbio pharmaceutical co., LTD

Fasting group; Feeding group

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

Siforl® is produced by Boehringer Ingelheim International Gmbh

Fasting group; Feeding group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Those who smoked more than 5 cigarettes per day in the first 3 months or could not stop using any tobacco products during the trial;
• Those who drank more than 14 units of alcohol per week (1 unit of alcohol ≈360 mL beer or 45 mL spirits with a 40% alcohol content or 150 mL wine) in the first 3 months or who could not abstain from alcohol during the trial;
• People who drank excessive amounts of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup =250 mL) every day for 3 months before screening;Or within 48 hours before the test, eat any food containing alcohol or rich in xanthine compounds (such as chocolate) and drink (such as tea, coffee, cola, etc.), grapefruit juice, etc；
• Lactose intolerant;
• Those who have special requirements on diet and cannot accept a uniform diet;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Hongguan biological pharmaceutical co.: collaborator

Study Sites (1)

The First Affiliated Hospital,ZheJiang Univercity

Hanzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Tablets

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jian Liu, Master

  The First Affiliated Hospital,ZheJiang Univercity

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: February 19, 2020
• Study Start: July 24, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 31, 2023

Record last verified: 2019-11

Locations

CN (1)