CompletedPhase 1

Bioequivalence Study of Pramipexole Dihydrochloride Extended-release Tablets in Healthy Chinese Subjects

China49 participantsStarted 2017-03-16

Plain-language 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 conditions.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cmax (Maximum Concentration)

Timeframe: 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)

Timeframe: From the start of administration to 72 hours post-dose

AUC(0-∞) (Area Under the Concentration-Time Curve from time 0 to infinity)

Timeframe: From the start of administration to 72 hours post-dose

Trial details

NCT IDNCT07519278

SponsorHaisco Pharmaceutical Group Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-04-11

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

What they're measuring

Cmax (Maximum Concentration)

Timeframe: 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)

Timeframe: From the start of administration to 72 hours post-dose

AUC(0-∞) (Area Under the Concentration-Time Curve from time 0 to infinity)

Timeframe: From the start of administration to 72 hours post-dose