NCT05186129已完成1 期
To Determine the Bioequivalence of Clopid® (Clopidogrel) 75 mg Tablet Manufactured by Ferozsons Laboratories Ltd. Pakistan and Plavix® 75 mg Tablet Manufactured by Sanofi Winthrop Industrie France for Sanofi Pakistan After Oral Administration to Healthy Adult Male Subjects Under Fasting Condition
Center for Bioequivalence Studies and Clinical Research1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年4月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
To compare the rate and extent of absorption of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® (clopidogrel) 75 mg tablet under fasting condition.
详细描述
Single dose, Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopid® of Ferozsons Laboratories Limited and Plavix® of Sanofi Winthrop Industrie France for Sanofi Pakistan Following a 75 mg Dose In Healthy Subjects Under Fasting Condition.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects , age between 18 to 55 years old
- •Body mass index (BMI) between 18.5-30.0 kg /m
- •Subject is willing to participate and to Sign written informed consent form
- •Subjects should have a blood pressure after resting for at least three minutes between 100-139 mmHg (systolic) and 60-89 mmHg (diastolic).
- •Subjects should have a supine (ECG) heart rate between 60 and 100 beats/min after resting for at least 3 minutes.
- •Ability to fast for 10 hours and consume standard meal.
- •Subjects must be in good health as determined by medical history, physical exmination, ECG, vital signs, medical tests including biochemistry, urinalysis, serology and hematology in serum/urine.
排除标准
- •• History of smoking , alcoholism, and a positive test for drugs of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- •Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
- •Subjects allergic to Clopidogrel and/or, subjects who received any investigational drug within four weeks prior to screening.
- •Intake of Smokeless tobacco, Tea, Coffee or other xanthenes derivatives (e.g. chocolate, cocoa) and poppy seeds 48 hours prior to study Check- In and must not consume grape fruit or juice of grape fruit at least 14 days prior to study.
- •Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
- •Ingestion of OTC drug, within 14 days of drug administration (e.g. aspirin, ibuprofen)
- •History of intake of any prescribed medicine during a period of 30 days, prior to drug administration day of study.
- •Other prescription medication such as Antidepressent (Bupripion), CYP2C19 inhibitors (cimetidine, esomeprazole, etravirine, felbamate, fluconazole, fluoxetine, fluvoxamine, ketoconazole, omeprazole, ticlopidine, voriconazole), Macrolide and related antibiotics (erythromycin, telithromycin), Proton pump inhibitors (esomeprazole, omeprazole), Rifamycins (rifampin) and Anti-Coagluant (Warfarin) should also not be taken before 14 days.
- •Individuals who had undergone any major surgery within 3 months prior to the start of the study, unless deemed eligible by the Principal Investigator or whomever he/she may designate.
- •Subject has a history of any illness that, in the opinion of investigator might confound the result of the study or post additional risk in administrating Clopidogrel to the subject.
- •Subjects having any external wound.
- •Inability to take oral medication.
- •Subjects with clinically significant abnormalities in investigations (safety assessments) as determined by the Investigator.
研究组 & 干预措施
Clopid® 75 mg(Clopidogrel)Tablet of Ferozsons Laboratories Ltd. Pakistan
Experimental
Single dose of Clopid® 75 mg Tablet administered under fasting condition
干预措施: Clopid® 75 mg Tablet (Drug)
Plavix® 75mg Tablet of Sanofi Winthrop Industrie France for Sanofi Pakistan.
Active Comparator
Single dose of Plavix® 75 mg Tablet administered under fasting condition
干预措施: Plavix® 75mg Tablet (Drug)
结局指标
主要结局
Cmax
时间窗: 0-36 hours post dose
maximum plasma concentration
AUC
时间窗: 0-36 hours post dose
Area under plasma concentration time curve
次要结局
- t 1/2(0-36 hours post dose)
- Tmax(0-36 hours post dose)
- Incidence of Treatment-Emergent Adverse Event(0-36 hours post dose)
研究者
Dr. Naghma Hashmi
Sub Investigator
Center for Bioequivalence Studies and Clinical Research
研究点 (1)
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