NCT06450236已完成1 期
An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Cross-over, Single Dose Bioequivalence Study of Perampanel Tablets 10 mg of Humanis Sağlık A.Ş., Turkey and Fycompa 10 mg Film-coated Tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Deutschland in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
Humanis Saglık Anonim Sirketi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum concentration obtained (Cmax)
研究概览
简要总结
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Perampanel Tablets 10 mg of Humanis Sağlık A.ġ., Turkey and Fycompa 10 mg film-coated tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Deutschland in normal, healthy, adult, human 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects fulfilling the following criteria were included in the study:
- •Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study;
- •Willing to be available for the entire study period and to comply protocol requirements;
- •Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age;
- •Body mass index in the range of 18.50 - 30.00 kg/m2 (both inclusive);
- •Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and physical examination at the time of screening as well as check-in of each study period;
- •Normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis;
- •Normal or clinically non-significant 12-lead ECG recording;
- •Non-smokers and willing to abstain from chewing any tobacco containing products at least 72.00 hours prior to check-in until last sample collection in each study period;
- •Non Alcoholic;
- •Willing to abstain from xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to check-in until last sample collection in each study period;
- •Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in until last sample collection in each study period;
- •For female subjects:
- •Negative urine pregnancy test during screening and negative serum β-hCG test at the time of check-in of each study period;
- •Female subjects with child bearing potential or those within their first two years of onset of menopausal syndrome willing to either abstain from sexual intercourse, or should use of acceptable birth control methods for at least 15 days before 1st check-in till 15 days post lastdose / entire study period. [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed)].
排除标准
- •Subjects with the following criteria were excluded from the study:
- •Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs;
- •Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;
- •Any major illness or hospitalized within 90 days prior to the first check-in;
- •Requiring medication for any ailment having enzyme-modifying activity within one month prior to first check-in and throughout the study;
- •Use of any depot injection or an implant of any drug within 3 months prior to first check-in and throughout the study;
- •History or presence of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •History of Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms(DRESS) and Stevens - Johnson Syndrome (SJS).
- •Use of any prescribed medication (including herbal medicines and vitamin supplements) or OTC products within 30 days prior to first check-in and throughout the study;
- •History or presence of significant gastric and/or duodenal ulceration;
- •Difficulty in swallowing tablets or capsules;
- •Use of any recreational drug or history of drug addiction;
- •Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 90 days prior to first check-in;
- •Positive urine alcohol and urine drug of abuse tests during check-in of each study period;
- •Reactive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies;
- •Lactating or nursing female subjects;
- •Female subjects using hormonal contraceptive (either oral/implants);
- •History of allergy or hypersensitivity intolerance to perampanel or its formulation excipients which, in the opinion of a clinical investigator, would compromise the safety of the subject or the study;
- •History of difficulty in accessibility of veins in arms.
研究组 & 干预措施
Perampanel Tablets
Experimental
Perampanel 10mg Tablets
干预措施: Perampanel 10 MG (Drug)
Fycompa film-coated tablets
Active Comparator
Fycompa 10mg film-coated tablets (Perampanel 10mg)
干预措施: Fycompa 10Mg Tablet (Drug)
结局指标
主要结局
Maximum concentration obtained (Cmax)
时间窗: 23 hours
two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax
AUC from time 0 to last collection time 72 (AUC0-72)
时间窗: 23 hours
two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data AUC0-72
次要结局
- Time of the maximum measured plasma concentration (Tmax)(23 hours)
研究者
研究点 (1)
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