A Single Center, Open Label, Randomized, Single-dose, 2 Way Cross-over Study to Explore the Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions in Healthy Male Pakistani Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Single oral administrations of study drug (Lamnet and Lamictal) in two periods separated by a washout period of 14 days. The washout period will be calculated from day of dosing (Day 2) to at least 14 days post dose in each period.
详细描述
The study drugs will be administered with 240 mL ambient Temperature water after at least 10 hours fasting in each periods.
Pharmacokinetic parameters include Lamotrigine plasma concentrations at the given sampling times. In each period 18 blood samples for plasma Lamotrigine concentrations will be taken on Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 (at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5 ,4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose.) The primary parameters to be analyzed are the maximum plasma concentration (Cmax), area under the plasma concentration-time curve from zero to the time of the last measurable time point t (AUClast or also termed as AUC0-t) and area under the plasma concentration-time curve from zero to infinity (AUCtotal or, also termed as AUC0-inf) and (AUC0-t)/ (AUC0-inf).
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 volunteers aged 18 to 55 years inclusive.
- •Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
- •Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate and temperature), ECG monitoring and laboratory analysis (ie, hematology, blood biochemistry, and urinalysis)and viral serology as determined by the investigator.
- •Tested negative for COVID-19 (through COVID-19 antibody testing).
- •Subjects should have negative urine test for drugs of abuse (morphine, cannabinoids will be tested) and alcohol breath analysis at screening and prior to each check-in.
- •Subjects will be able to, understand and sign the Informed Consent Form for Medical Screening during their screening visit and Participation Informed Consent Form on study check-In day.
- •Subject agreed not to use special diet including fasting, high protein diet within the next 4 weeks.
- •Subject agreed not to consume Alcohol, cigarette, gutka, caffeine or related xanthines containing foods or beverages (e.g. tea, coffee, cola drinks, chocolates, cocoa) etc and poppy seeds (khash khash) within 48 hours prior to drug administration.
- •Subject agreed not to intake prescription drugs within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medicine.
- •Subject agreed not to intake non-prescription drugs (OTC) within 14 days prior to first dose of study medicine.
- •Subject agreed to discontinue vitamins ,dietary and herbal supplements within 14 days prior to the first dose of study medication.
- •Subject agreed not to consume grapefruit and/or its products within 14 days prior to the start of study.
排除标准
- •Inability to take oral medication.
- •Tested positive for COVID-19 (through COVID-19 antibody testing).
- •History of smoking (≤3cigarette/day), alcoholism, and positive test for drug 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.
- •Subject is allergic to Lamotrigine and any of the product of lamotrigine .
- •Subject has received any investigational drug within four weeks.
- •Participated in any clinical trials within 30 days.
- •Subjects with salt imbalance in the blood (especially low levels of potassium or magnesium in the blood).
- •Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
- •History of any significant illness in the last four weeks which might confound in the result of the study or post additional risk in administrating lamotrigine to the subject.
- •Concomitant treatment with Valproate, Carbamazepine, phenytoin, phenobarbital, primidone,, rifampin, Estrogen-containing oral contraceptives, Protease inhibitors lopinavir/ritonavir and atazanavir/lopinavir.
- •Subjects who test positive for syphilis (VDRL) or who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2).
- •Individuals having undergone any major surgery within 3 months prior to the start of the study, unless deemed eligible, otherwise by the Principal Investigator or whomever he/she may designate.
- •Subjects with any condition, which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or elimination of drugs.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •History of asthma, anaphylaxis or anaphylactic reactions, severe allergic responses.
- •Current or past history of nervous-psychiatric disorder, in the opinion of investigator that the subject is at risk of suicide or with history of suicide behavior/attempt.
研究组 & 干预措施
Test Group
Oral administration of Lamnet (100mg) Tablet after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point.
干预措施: Lamotrigine tablet (Drug)
Reference Group
Oral administration of Lamictal (100mg) Tablet after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point.
干预措施: Lamotrigine tablet (Drug)
结局指标
主要结局
Cmax
时间窗: 0-120 hours post dose
maximum plasma concentration of Lamotrigine
AUC
时间窗: 0 to 120 hours post dose
Area Under the Plasma Drug Concentration versus Time curve
Tmax
时间窗: 0-120 hours post dose
Time required for maximum plasma drug concentration
次要结局
- Body temperature measurement(0-120 hours post dose)
- Blood Pressure monitoring(0-120 hours post dose)
- Heart rate measurement(0-120 hours post dose)
研究者
Dr. Muhammad Raza Shah
Professor
University of Karachi