Parkinson's DiseasePLKS-BENCT04275492

Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets

A study testing Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride) and Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole) in people with Parkinson's Disease, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson's Disease
What is being tested?: Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride) and Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 24 Jul 2020to 1 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

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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;
The test of hepatitis b surface antigen, hepatitis c virus antibody, anti-human immunodeficiency virus antibody or anti-syphilis spirochete specific antibody has one or more clinical significance;
Women who have positive pregnancy test results and are lactating, pregnant or planning to have a recent pregnancy;
Those with positive alcohol test results or positive screening for drug abuse (morphine, methamphetamine, ketamine, dimethylene dioxymethamphetamine and tetrahydrocannabinic acid);
Other subjects deemed unsuitable by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital,ZheJiang Univercity
Hanzhou, Zhejiang, 310000

Other trials in China

About this study

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.

Read the 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:

Study on human bioequivalence of drug administration on an empty stomach: 30 healthy subjects (male and female).
Human bioequivalence of high-fat post-meal administration: 30 healthy subjects (male and female).

Conditions: Parkinson's Disease
Being tested: Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride), Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)
Keywords: Pramipexole Dihydrochloride Sustained Release Tablets
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)Drug
Siforl® is produced by Boehringer Ingelheim International Gmbh

Study groups in NCT04275492
Study group	Role	What they receive
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. Receives: 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. Receives: 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
Maximum observed plasma concentration
Measured: [time range: 72 hours post-dose on Day 1,8]
Tmax
Time to maximum plasma concentration
Measured: [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
Measured: [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
Measured: [time range: 72 hours post-dose on Day 1,8]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jul 20201 Dec 2020

First posted19 Feb 2020
Study start24 Jul 2020
Primary completion1 Oct 2020
Study completion1 Dec 2020

Why it stopped: The sponsor terminated the clinical trial

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04275492
Sponsor's protocol ID: ZYYY-PLKS-BE-2019-02
Acronym: PLKS-BE
Status last verified: Nov 2019
First submitted: 18 Nov 2019
Last updated: 31 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets
ClinicalTrials.gov ID: NCT04275492
Acronym / sponsor ID: PLKS-BE / ZYYY-PLKS-BE-2019-02
Conditions: Parkinson's Disease
Keywords: Pramipexole Dihydrochloride Sustained Release Tablets
Study type: Interventional
Recruitment status: TerminatedReason stopped: The sponsor terminated the clinical trial
Enrolment: 30 participants (actual)
Lead sponsor: First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
Collaborators: Hongguan biological pharmaceutical co.
Study start: 24 Jul 2020 (actual)
Primary completion: 1 Oct 2020 (actual)
Study completion: 1 Dec 2020 (actual)
First posted: 19 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A secondary purpose To evaluate the safety of fasting and postprandial oral test preparations and reference preparations.

Detailed description

A total of 60 healthy subjects were enrolled into the equivalence test, among which:

Study on human bioequivalence of drug administration on an empty stomach: 30 healthy subjects (male and female).
Human bioequivalence of high-fat post-meal administration: 30 healthy subjects (male and female).

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fasting group	Experimental	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)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.
Feeding group	Experimental	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)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.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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);

Key exclusion criteria (19 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Fasting group, Feeding group
Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)Siforl® is produced by Boehringer Ingelheim International Gmbh	Drug	Fasting group, Feeding group

Primary outcome

Cmax
Time frame: [time range: 72 hours post-dose on Day 1,8]
Maximum observed plasma concentration
Tmax
Time frame: [time range: 72 hours post-dose on Day 1,8]
Time to maximum plasma concentration
AUC（0-inf）
Time frame: [time range: 72 hours post-dose on Day 1,8]
Area under a time curve of plasma concentration from time 0 to infinity
AUC（0-72h）
Time frame: [time range: 72 hours post-dose on Day 1,8]
Area under the concentration-time curve 0 to 72 h after administration

Results and safety

The study was stopped early (reason given: The sponsor terminated the clinical trial). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.

Related trials for Parkinson's Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jian Liu, Master study chair

The First Affiliated Hospital,ZheJiang Univercity

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The sponsor terminated the clinical trial). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: [time range: 72 hours post-dose on Day 1,8]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04275492.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.