Bioequivalence Study of 0.25 mg Pramipexole Tablets Produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals in Comparison With the Comparator Product (Sifrol® 0.25 mg Tablet, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim International, GmbH, Germany)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
The present study was conducted to find out whether the bioavailability of 0.25 mg pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was equivalent to the reference drug (Sifrol® tablet 0.25 mg, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).
详细描述
This was a randomized, open label, two-period, two-sequence, crossover study under fasting condition. The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Pramipexole 0.25 mg produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals) or one tablet of the reference drug (Sifrol® 0.25 mg, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).
Blood samples were drawn immediately before taking the drug (control), at 20, 40 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration. Seven days after the first drug administration (washout period), the procedure was repeated using the alternate drug. The plasma concentrations of pramipexole were determined by validated ultra performance liquid chromatography with mass spectrometry detector (UPLC-MS/MS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects
- •Preferably non-smokers or smoke less than 10 cigarettes per day
- •Body mass index within 18 to 25 kg/m2
- •Normal vital signs (after 10 minutes rest): systolic blood pressure 100 - 120 mmHg, diastolic blood pressure 60 - 80 mmHg, pulse rate 60 - 90 bpm
排除标准
- •Personal / family history of allergy or hypersensitivity or contraindication to pramipexole or allied drugs
- •Pregnant or lactating women
- •Any major illness in the past 90 days or clinically significant ongoing chronic medical illness
- •Any clinically significant abnormal values of liver function test (ALT, alkaline phosphatase, total bilirubin >= 1.5 upper limit normal), renal function test (serum creatinine > 1.4 mg/dL), etc
- •Positive Hepatitis B surface antigen (HbsAg), anti-HCV, or anti-HIV
- •Clinically significant hematology abnormalities
- •Clinically significant ECG abnormalities
- •Any surgical or medical condition (present or history) which might significantly alter the pharmacokinetics of the study drug
- •History of anaphylaxis or angioedema
- •History of drug or alcohol abuse within 12 months prior to screening
- •Participation in any clinical trial within the past 90 days
- •History of any bleeding or coagulative disorders
- •History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm
- •A donation or loss of 300 mL (or more) of blood within 3 months before the study's first dosing day
- •Intake of any prescription, non-prescription drug, food supplement or herbal medicine within 14 days of the study's first dosing day
研究组 & 干预措施
Pramipexole Dexa Medica
Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate. An oral single dose of the tablet was administered at the first day of each treatment period.
干预措施: Pramipexole Dexa Medica (Drug)
Pramipexole Boehringer Ingelheim Pharma
Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate. An oral single dose of the tablet was administered at the first day of each treatment period.
干预措施: Pramipexole Boehringer Ingelheim Pharma (Drug)
结局指标
主要结局
AUCt
时间窗: 48 hours
Area under plasma concentration time curve from time zero to the last observed quantifiable concentration was determined from plasma concentrations of pramipexole from the test drug and reference drug.
AUCinf
时间窗: 48 hours
Area under plasma concentration time curve from time zero to infinity was determined from plasma concentrations of pramipexole from the test drug and reference drug.
Cmax
时间窗: 48 hours
The peak plasma concentration of the drug was determined from plasma concentrations of pramipexole from the test drug and reference drug.
次要结局
- Tmax(48 hours)
- T1/2(48 hours)