HealthyPhase 1NCT07519278
Bioequivalence Study of Pramipexole Dihydrochloride Extended-release Tablets in Healthy Chinese Subjects
A Phase 1 study testing Test formulation（pramipexole dihydrochloride extended-release tablets） and Reference formulation（MIRAPEX ER®） in people with Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
The study compared pramipexole dihydrochloride extended-release tablets (Test formulation) by Haisco Pharmaceutical Group Co., Ltd. with the reference formulation (MIRAPEX ER®，Boehringer Ingelheim GmbH of Germany) to evaluate the bioequivalence of single dose in Chinese healthy subjects under fasting and fed… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test formulation（pramipexole dihydrochloride extended-release tablets） and Reference formulation（MIRAPEX ER®）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2017to 12 Feb 2018
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects aged 18 years or older (inclusive);
- Body weight ≥ 50 kg for males and ≥ 45 kg for females, with body mass index (BMI) between 19 and 26 (inclusive);
- No clinically significant abnormalities in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), chest X-ray (posteroanterior view), or abdominal ultrasound at screening；
- All subjects must be willing to use appropriate contraceptive measures from the screening period, throughout the trial drug administration period, and until one month after drug discontinuation;
- Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
Who cannot join
- Subjects with serious systemic diseases, infectious diseases, or mental disorders that, in the investigator's opinion, make them unsuitable for participation in this study;
- History of clinically significant ECG abnormalities or family history of long QT syndrome (grandparents, parents, and siblings);
- Known or suspected history of allergy to the investigational drug or drugs with a similar chemical structure;
- Presence of conditions that may affect drug absorption, distribution, metabolism, or excretion, including but not limited to any of the following:
- History of inflammatory bowel disease, gastritis, gastrointestinal ulcer, gastrointestinal bleeding, or other clinically significant gastrointestinal abnormalities.
- History of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, enterectomy, gastric bypass, gastric partitioning, or gastric banding).
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- History of clinically significant renal disease or impaired renal function, or laboratory abnormalities at screening.
- Liver disease or laboratory abnormalities indicative of clinically significant hepatic impairment at screening.
- Subjects with positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or syphilis antibody;
- History of drug abuse or alcohol abuse within 12 months prior to screening (consuming more than 2 units of alcohol per day or more than 14 units per week; 1 unit = 355 mL beer, 30 mL liquor, or 150 mL wine);
- Average daily smoking of more than 5 cigarettes within 3 months prior to screening (assessed by interview at screening), or inability to refrain from smoking during the entire study period;
- Blood donation or blood loss of ≥ 400 mL within 3 months prior to screening;
- Participation in another clinical trial within 3 months prior to screening;
- Use of any prescription medication within 4 weeks prior to screening;
- Use of over-the-counter drugs, health supplements, herbal medicines, or traditional Chinese medicines within 2 weeks prior to screening. Refusal to discontinue any beverages or foods containing xanthines, such as caffeine (coffee, tea, cola, chocolate, etc.), from 48 hours before dosing until the end of the study;
- Pregnant or breastfeeding women;
- History of orthostatic hypotension, sudden vertigo, or transient syncope;
- Subjects deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The General Hospital of Western Theater Command PLA
Chengdu, Sichuan
About this study
Official title: Comparative Pharmacokinetics for Bioequivalence of Pramipexole Dihydrochloride Extended-Release Tablets in Fasting and Fed Chinese Healthy Volunteers: A Randomized, Open-label, Single-dose, Crossover Study
The study compared pramipexole dihydrochloride extended-release tablets (Test formulation) by Haisco Pharmaceutical Group Co., Ltd. with the reference formulation (MIRAPEX ER®，Boehringer Ingelheim GmbH of Germany) to evaluate the bioequivalence of single dose in Chinese healthy subjects under fasting and fed conditions.
- Conditions
- Healthy
- Being tested
- Test formulation（pramipexole dihydrochloride extended-release tablets）, Reference formulation（MIRAPEX ER®）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test formulation（pramipexole dihydrochloride extended-release tablets）Drug
Test formulation (pramipexole dihydrochloride extended-release tablets, Haisco Pharmaceutical Group Co., Ltd), A single oral dose of 0.375 mg, taken with 240mL of water
Reference formulation（MIRAPEX ER®）Drug
Reference formulation (pramipexole dihydrochloride extended-release tablets, Boehringer Ingelheim GmbH of Germany), A single oral dose of 0.375 mg, taken with 240mL of water
| Study group | Role | What they receive |
|---|---|---|
| Test formulation | Experimental | pramipexole dihydrochloride extended-release tablets (0.375 mg/table)，Manufacturer: Haisco Pharmaceutical Group Co., Ltd Receives: Drug: Test formulation（pramipexole dihydrochloride extended-release tablets） |
| Reference formulation | Experimental | pramipexole dihydrochloride extended-release tablets (MIRAPEX ER®，0.375 mg/table) Manufacturer: Boehringer Ingelheim GmbH of Germany Receives: Drug: Reference formulation（MIRAPEX ER®） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum Concentration)
The pharmacokinetic parameters of pramipexole in plasma
Measured: From the start of administration to 72 hours post-dose
AUC(0-t) (Area Under the Concentration-Time Curve from time 0 to time t)
The pharmacokinetic parameters of pramipexole in plasma
Measured: From the start of administration to 72 hours post-dose
AUC(0-∞) (Area Under the Concentration-Time Curve from time 0 to infinity)
The pharmacokinetic parameters of pramipexole in plasma
Measured: From the start of administration to 72 hours post-dose
Secondary outcomes (1)
AEs (Adverse Events)
The incidence and severity of AEs
Measured: From the time of signing ICF (Informed Consent Form) to the end of follow-up，up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start16 Mar 2017
- Primary completion11 Apr 2017
- Study completion12 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519278
- Sponsor's protocol ID
- HSK-80-BE-2016
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Q, Shi HQ, Chen YF, Zhang W, Ye L, Li YM, Hu TT. Comparative pharmacokinetics for bioequivalence of pramipexole dihydrochloride extended-release tablets in fasting and fed Chinese healthy volunteers: a randomized, open-label, single-dose, crossover study. BMC Pharmacol Toxicol. 2026 May 11;27(1):94. doi: 10.1186/s40360-026-01144-w.
PubMed 42116205
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetics for Bioequivalence of Pramipexole Dihydrochloride Extended-Release Tablets in Fasting and Fed Chinese Healthy Volunteers: A Randomized, Open-label, Single-dose, Crossover Study
- ClinicalTrials.gov ID
- NCT07519278
- Acronym / sponsor ID
- HSK-80-BE-2016
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 9 Apr 2026 (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.
The study compared pramipexole dihydrochloride extended-release tablets (Test formulation) by Haisco Pharmaceutical Group Co., Ltd. with the reference formulation (MIRAPEX ER®，Boehringer Ingelheim GmbH of Germany) to evaluate the bioequivalence of single dose in Chinese healthy subjects under fasting and fed conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test formulation | Experimental | Drug: Test formulation（pramipexole dihydrochloride extended-release tablets）pramipexole dihydrochloride extended-release tablets (0.375 mg/table)，Manufacturer: Haisco Pharmaceutical Group Co., Ltd |
| Reference formulation | Experimental | Drug: Reference formulation（MIRAPEX ER®）pramipexole dihydrochloride extended-release tablets (MIRAPEX ER®，0.375 mg/table) Manufacturer: Boehringer Ingelheim GmbH of Germany |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male and female subjects aged 18 years or older (inclusive);
- Body weight ≥ 50 kg for males and ≥ 45 kg for females, with body mass index (BMI) between 19 and 26 (inclusive);
- No clinically significant abnormalities in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), chest X-ray (posteroanterior view), or abdominal ultrasound at screening；
- All subjects must be willing to use appropriate contraceptive measures from the screening period, throughout the trial drug administration period, and until one month after drug discontinuation;
- Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
Key exclusion criteria (18 listed)
- Subjects with serious systemic diseases, infectious diseases, or mental disorders that, in the investigator's opinion, make them unsuitable for participation in this study;
- History of clinically significant ECG abnormalities or family history of long QT syndrome (grandparents, parents, and siblings);
- Known or suspected history of allergy to the investigational drug or drugs with a similar chemical structure;
- Presence of conditions that may affect drug absorption, distribution, metabolism, or excretion, including but not limited to any of the following:
- Subjects with positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or syphilis antibody;
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 |
|---|---|---|
| Test formulation（pramipexole dihydrochloride extended-release tablets）Test formulation (pramipexole dihydrochloride extended-release tablets, Haisco Pharmaceutical Group Co., Ltd), A single oral dose of 0.375 mg, taken with 240mL of water | Drug | Test formulation |
| Reference formulation（MIRAPEX ER®）Reference formulation (pramipexole dihydrochloride extended-release tablets, Boehringer Ingelheim GmbH of Germany), A single oral dose of 0.375 mg, taken with 240mL of water | Drug | Reference formulation |
Primary outcome
Cmax (Maximum Concentration)
Time frame: From the start of administration to 72 hours post-dose
The pharmacokinetic parameters of pramipexole in plasma
AUC(0-t) (Area Under the Concentration-Time Curve from time 0 to time t)
Time frame: From the start of administration to 72 hours post-dose
The pharmacokinetic parameters of pramipexole in plasma
AUC(0-∞) (Area Under the Concentration-Time Curve from time 0 to infinity)
Time frame: From the start of administration to 72 hours post-dose
The pharmacokinetic parameters of pramipexole in plasma
1 secondary outcome
AEs (Adverse Events)
Time frame: From the time of signing ICF (Informed Consent Form) to the end of follow-up，up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 42116205Chen Q, Shi HQ, Chen YF, Zhang W, Ye L, Li YM, Hu TT. Comparative pharmacokinetics for bioequivalence of pramipexole dihydrochloride extended-release tablets in fasting and fed Chinese healthy volunteers: a randomized, open-label, single-dose, crossover study. BMC Pharmacol Toxicol. 2026 May 11;27(1):94. doi: 10.1186/s40360-026-01144-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test formulation（pramipexole dihydrochloride extended-release tablets） and Reference formulation（MIRAPEX ER®） in people with Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
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 5 inclusion and 18 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: finished, as of the sponsor's last update on 14 Apr 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (Maximum Concentration) (time frame: From the start of administration to 72 hours post-dose). The study lists 3 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 NCT07519278, which also lists 1 linked publication.
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 14 Apr 2026.