NCT07146711进行中（未招募）1 期
A Prospective, Randomised, Open Label, Multiple Dose, Two-treatment, Two-period, Two-sequence, Crossover Bioequivalence Study of Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Tablets (Synthon Hispania SL, Spain) Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets (Astellas Pharma Europe B.V., the Netherlands), in Healthy Adult Male Subjects, at Steady State
Berlin-Chemie AG Menarini Group1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年3月3日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Cmax,ss
研究概览
简要总结
The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0,4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands), in healthy adult male subjects, at steady state.
详细描述
The assessment of the bioequivalence of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), and Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands) after multiple dose administration in healthy male subjects at steady state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Capable of understanding the informed consent form (ICF) and giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •Healthy male subjects aged 18 to 45 years inclusive, at the time of signing the ICF, able to tolerate venipuncture.
- •Verified diagnosis of being "healthy" according to results of standard clinical, laboratory and instrumental methods of examination.
- •Body weight ≥50 kg and ≤ 120 kg, Body Mass Index between ≥18.5 and ≤30.0 kg/m
- •Non-smokers (for at least 3 months).
- •Subjects should be willing to remain abstinent (refrain from heterosexual intercourse) or use double barrier contraception during participation in the study and for 30 days thereafter. Double-barrier contraceptive method: condom used together with spermicidal foam/gel/film/cream/suppository.
排除标准
- •History or presence of allergies.
- •Known hypersensitivity or intolerance to tamsulosin and/or other alpha1 adreno-receptor antagonists and/or any excipient of the study drugs.
- •History of drug-induced angioedema.
- •History, presence or necessity of glaucoma or cataract surgery.
- •History or presence of acute or chronic diseases of cardiovascular (including arterial hypotension), bronchopulmonary, nervous, endocrine, reproductive systems (including ejaculation disorders), and also diseases of the gastrointestinal tract, liver (including hepatic insufficiency), urinary tract and kidneys (including renal insufficiency), blood, mental diseases; history of convulsive attacks.
- •Acute infectious diseases (e.g. influenza, acute respiratory viral infections incl. COVID-19) less than 4 weeks before the first IMP administration.
- •The presence of any other condition which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.
- •Surgery on the gastrointestinal tract (except appendectomy).
- •Deviations from the normal parameters in clinical blood count analysis, biochemical blood analysis, urinalysis.
- •History or presence of orthostatic hypotension or syncope.
- •Systolic blood pressure measured in a sitting position, less than 100 mmHg or above 130 mmHg and/or diastolic blood pressure below 60 mmHg or above 89 mmHg.
- •Heart rate less than 60 or more than 80 beats per minute.
- •Deviation on the ECG intervals and heart rate or ECG morphology.
- •Positive test results for HIV or hepatitis B or C or syphilis at screening.
- •Positive test result for cotinine in the urine at screening or before randomisation.
- •Positive screen for drugs or alcohol at screening or before randomisation.
- •Known or suspected drug or alcohol abuse as judged by the Investigator.
- •Alcohol consumption more than 10 units of alcohol a week (1 unit equivalent to 200 ml of dry wine or 50 ml of strong alcoholic drinks or 500 ml of beer) during the six months prior to the first administration of the IMP.
- •Intake of xanthine containing substances (e.g., coffee, tea, chocolate, energy drinks, cola) as well as citrus fruits (grapefruit, grapefruit juice etc.) and cranberry (including juices, fruit drinks, etc.) within the last 72 hours before the IMP administration.
- •Administration of medicines that have a significant effect on circulatory dynamics, liver function, etc. (barbiturates, omeprazol, cimetidin, NSAIDs, ACE inhibitors, angiotensin II receptor antagonists, diuretics, etc.) less than 2 months or 5 half-lives (whatever is longer) before screening.
- •The use of depot-forms of any drugs for 3 months or 5 half-lives (whatever is longer) before screening.
- •Use of any prescribed or non-prescribed medication, herbal remedies, vitamins and minerals during the two weeks prior to the first administration of the IMP or longer (at least 5 elimination half-lives) if the medication has a long half-life.
- •Mental, physical and other reasons that do not allow the subjects according to investigator's opinion to assess their behavior adequately, to follow correctly the requirements of the clinical study protocol and to assess the expected risks and possible discomfort.
- •Dehydration (e.g. due to diarrhea, vomiting, or other causes) within the last 48 hours before the IMP administration.
- •Subjects who have been on a special diet (for whatever reason, e.g. vegetarians or hypocaloric diet [less than 1000 cal/day]) during the 28 days prior to the first IMP administration and intention to maintain the diet during the study.
- •Intention to perform excessive physical activities during the trial.
- •Plasma donation within one month of screening or blood donation/blood loss >500 ml within 3 months before screening.
- •Unwillingness or inability to follow the procedures and restrictions outlined in the protocol and the ICF.
- •Participation in another clinical study within 3 months before the first IMP administration.
- •Difficulty swallowing tablets or fasting or consuming standard meals.
- •Any reason in the opinion of the Investigator, would prevent the subject from participating in the study.
- •Scheduled to have vaccination during the study.
研究组 & 干预措施
Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets of Synthon Hispania SL, Spain
Experimental
Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets of Astellas Pharma Europe B.V., the Netherlands
干预措施: Tamsulosin (0.4 mg/j) (Drug)
Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets of Astellas Phar
Active Comparator
Multiple dose administration (7 days)
干预措施: Omnic Ocas®, (Drug)
结局指标
主要结局
Cmax,ss
时间窗: 7 days
Maximum plasma concentration at steady state
AUC(0-tau),ss
时间窗: 7 days
Area under the curve at steady state
Ctau,ss
时间窗: 7 days
Plasma concentration at the end of the dosing interval at steady state
次要结局
- Cavg,ss(7 days)
- Tmax,ss(7 days)
- Cmin,ss(7 days)
- Kel(7 days)
- PTF(7 Days)
- T 1/2(7 days)
- Swing(7 days)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin 0.4 mg Tablets, in Healthy Adult Male Subjects, Under Fed ConditionsNCT07091669Berlin-Chemie AG Menarini Group46
已完成
1 期
Bioequivalence Study of Tamsulosin 0.4 mg Sustained Release Film-coated TabletsHealthyNCT06558032Dexa Medica Group28
招募中
不适用
Clinical study to compare the in vivo parameters of 2 Tamsulosin 0.4 mg ER Capsule formulationsIRCT20180620040164N28Cosar pharmaceutical Co.24
已完成
不适用
Clinical study to compare the in vivo parameters of 2 Tamsulosin 0.4 mg ER Capsule formulationsIRCT20180620040164N26Dorsa Pharmaceutical Co.24
已完成
2 期
Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic BladderBladder, NeurogenicNCT00796614Boehringer Ingelheim231