A Single Center, Open Label, Randomized, Single-dose, Two-period, Two-way Cross-over Study to Compare the Rate and Extent of Absorption of Mofest® 400mg (Moxifloxacin) Tablet With Avelox® 400mg (Moxifloxacin) Tablet in Healthy Pakistani Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
Single oral dose, of test and reference Tablet will be administered to healthy volunteers, after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-points. Blood samples will be taken up to 72.0 hours post-dose.
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 subjects aged 18 to 55 years inclusive.
- •Subjects with a body mass index (BMI) from 18.5 to 30 kg/m
- •Subject is able to fast for 14 hours and consume standard meals.
- •Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate, and temperature), 12-Lead ECG, and safety laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis) or viral serology as determined by the investigator.
- •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 who are 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 consume food or beverages including dairy products, tea, coffee, cola drinks, chocolates containing xanthine derivatives (including caffeine, theobromines, etc.) and/or poppy seeds (Khash khash) within 48 hours prior to drug administration until last blood draw in each study period.
- •Subject agreed not to intake prescription drugs (especially amiodarone, carbamazepine, Antacids (aluminum and magnesium hydroxides) NSAIDS, digoxin and Blood thinners such as warfarin, etc.) within 14 days or 5 half-lives (whichever is longer) prior to 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
- •Subjects who refused to sign Informed Consent Form.
- •Subject not able to take medicine orally.
- •Pregnant and lactating females.
- •History of smoking ≥3 cigarette/day, alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- •Subject has clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematological/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 known to be allergic to Moxifloxacin and/or other Quinolones antibiotics
- •Subject who has received any other investigational drug within four weeks.
- •Subject who has participated in any other clinical trials within 3 months.
- •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 Moxifloxacin to the subject.
- •Subjects tested positive for syphilis (VDRL) or is known to have serum hepatitis or carrier 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).
研究组 & 干预措施
Test Group
Subjects will be given one Mofest® 400mg (Moxifloxacin HCl) Tablet (1x400mg) manufactured by SAMI Pharmaceuticals (Pvt.) after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. Blood samples will be taken up to 72.0 hours post-dose.
干预措施: Moxifloxacin 400mg (Drug)
Reference Group
Subjects will be given one Avelox® 400mg (Moxifloxacin HCl) Tablet (1x400mg), manufactured by Bayer HealthCare, after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. Blood samples will be taken up to 72.0 hours post-dose.
干预措施: Moxifloxacin 400mg (Drug)
结局指标
主要结局
AUC
时间窗: 0-72 hours
Area under the time versus plasma drug concentration curve
maximum plasma concentration
时间窗: up to 72 hours post dose
maximum drug concentration in plasma after dose
Time to reach maximum plasma concentration
时间窗: 0 to 72 hours post dose
Time required for the drug to reach maximum plasma concentration
次要结局
未报告次要终点
研究者
Dr. Muhammad Raza Shah
Professor
University of Karachi