CTRI/2020/03/024192已完成1 期
An open-label, randomized, single-dose, two-treatment, two-sequence, two-way crossover bioequivalence study of Pramipexole prolonged-release tablet Aristo 1.05 mg, manufactured by Advance Pharma GmbH, Germany (Test) with Sifrol 1.05 mg Retardtabletten (prolonged-release 1.05 mg oral tablets), manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany (Reference), with at least 07 days washout period between each administration, in healthy, adult, male, human subjects under fasting condition - BSPPRT
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •(i)Healthy, Asian, male, human volunteer aged from 18 to 45 years.
- •(ii)Weight: 65 kg to 85 kg
- •(iii)Body Mass Index (BMI) should be within 18.5-30.0 kg/m2.
- •(iv)Voluntarily willing and capable to give written and signed informed consent prior to participation in the study, according to the form attached in appendix 1.
- •(v)Availability for the entire study period and willingness to adhere to protocol and study requirements.
- •(vi)Volunteers willing to undergo pre and post-study physical examinations and laboratory investigations.
- •(vii)Having no significant disease or abnormal laboratory values on laboratory examination with no clinical relevance, medical history or physical examination during screening.
- •(viii)12-lead ECG in resting position and vital signs are within normal limits or showing abnormalities, which the investigator does not consider of clinical relevance.
- •(ix)Normal chest X-ray findings or findings that have no clinical correlation.
- •(x)Non-smokers or ex-smokers who gave up smoking for at least 2 years prior to the study.
- •(xi)Having not consumed alcohol at least 48 hours prior to IMP administration justified by negative breath-alcohol test and who agree not to consume any amount of alcohol throughout the conduct of the study.
- •(xii)The subject agrees to abstain from coffee and other food and drinks containing methylxanthines (tea, cola, chocolate), grapefruit-containing food and beverages and chewing gum for 48 hours prior to the study drug administration and during each study period.
- •(xiii)Negative urine test for drug of abuse (amphetamine, barbiturate, tetrahydrocanabinoids, morphine, cocaine, benzodiazepine).
排除标准
- •(i)History of allergy or hypersensitivity to pramipexole or history of any drug hypersensitivity or intolerance, which, in the opinion of the investigator, would compromise the safety of the subject or the study.
- •(ii)History of or signs or symptoms of Parkinsonâ??s disease.
- •(iii)History of diseases of liver or hepatic impairment within last one (1) year
- •(iv)Elevated serum transaminases (SGOT/ SGPT) or alkaline phosphatase (at least 1.5 times of upper normal range).
- •(v)History of mania or hypomania.
- •(vi)Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration.
- •(vii)Participation in another clinical study or a blood donation program or have had blood loss of more than 350 ml during the last 90 days.
- •(viii)Renal insufficiency (serum creatinine more than twofold of the > 3 mg/dL).
- •(ix)Seropositive for VDRL, HIV or hepatitis B or C infection.
- •(x)Any clinically significant abnormality (to be determined by the investigator) following review of screening laboratory data and full physical examination.
- •(xi)Vital sign abnormalities (systolic blood pressure in supine position lower than 90 or higher than 140 mm Hg or diastolic blood pressure lower than 50 or higher than 100 mm Hg or heart rate less than 50 bpm or more than 120 bpm) at screening and at pre-admission physical examination.
- •(xii)Having suffered any illness within a week of starting the study or who have been hospitalized within the 3 months preceding the start of the study.
- •(xiii)Having taken over the counter (OTC) or prescribed medications, including any antihypertensive drugs, enzyme-modifying drugs or any systemic medication within the 07 days prior to the study (However, paracetamol may be permitted up to 03 days prior to the start of the study).
- •(xiv)Have a history of substance abuse within the last 5 years.
- •(xv)Consumption of methylxanthine-containing derivatives (coffee, tea, cola drinks, chocolate) within 48 hrs before IMP administration and grapefruit or orange juice for at least 48 hrs prior to IMP administration.
- •(xvi)Habit of chewing or inhaling nicotine-containing products (e.g. tobacco) currently or within last six months prior to the study.
- •(xvii)Abnormal INR combined with clinical manifestation.
- •(xviii)Subject is vegetarian or follows particular diets.
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