Bioequivalence Study of Pramipexole Dihydrochloride Extended-release Tablets in Healthy Chinese S… (NCT07519278) | Clinical Trial Compass
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 range18 Years
SexALL
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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
✕. 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;
What they're measuring
1
Cmax (Maximum Concentration)
Timeframe: From the start of administration to 72 hours post-dose
2
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
3
AUC(0-∞) (Area Under the Concentration-Time Curve from time 0 to infinity)
Timeframe: From the start of administration to 72 hours post-dose
✕. 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;