An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioavailability Study Comparing Oxcarbazepine 300 mg/5mL Oral Suspension of OHM Laboratories (a Subsidiary of Ranbaxy Pharmaceuticals Inc.) With Trileptal® 300 mg/5mL Oral Suspension (Containing Oxcarbazepine 300 mg/5mL) of Novartis Pharmaceutical Corporation in Healthy, Adult, Male, Human Subjects Under Fed Condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bioequivalence evaluation of ranbaxy Oxcarbazepine oral suspension 300 mg/5mL under fed condition
研究概览
简要总结
The purpose of this study is to compare the single-dose oral bioavailability of oxcarbazepine 300 mg/5mL oral suspension of OHM Laboratories, USA (a subsidiary of Ranbaxy Pharmaceuticals Inc.) with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of Novartis Pharmaceutical Corporation, USA in healthy, adult, male, human subjects under fed conditions.
详细描述
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing oxcarbazepine 300 mg/5mL oral suspension of OHM Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc.) with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of Novartis Pharmaceutical Corporation in healthy, adult, male, human subjects under fed condition.
Following an overnight fast of at least 10 hours, all subjects were served a high-fat high calorie breakfast. Thirty minutes after the start of the meal, a single oral dose of 10 mL of oxcarbazepine 300 mg/5 mL oral suspension was administered using a 10 mL graduated syringe, during each period of the study under the supervision of trained study personnel, along with 240 mL of drinking water at ambient temperature.
During the course of the study safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Laboratory parameters of hematology and biochemistry were repeated at the end of the study.
A total of forty (40) subjects were enrolled into the study, to be administered a single oral dose of the test or reference formulation of 10 mL of oxcarbazepine 300 mg/5 mL oral suspension according to a randomization schedule. Thirty-three (33) subjects completed both the periods of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Were in the age range of 18-45 years.
- •Were neither overweight nor underweight for the corresponding height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- •Had voluntarily given written informed consent to participate in this study.
- •Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
- •Had a non-vegetarian diet habit.
- •There were no deviations in this regard.
排除标准
- •History of hypersensitivity to oxcarbazepine, carbamazepine or to any related drugs.
- •History of hyponatremia, diplopia.
- •Recent history of dizziness, somnolence, and abdominal pain.
- •Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- •Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- •Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for hemoglobin, total white blood cells count, differential WBC count or platelet count.
- •Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
- •Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
- •Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
- •Clinically abnormal ECG or Chest X-ray.
- •History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
- •History of any psychiatric illness, which might impair the ability to provide written informed consent.
- •Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
- •History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
- •Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
- •Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
- •Subjects who, through completion of this study, had donated and/or lost more than 350 mL of blood in the past 3 months.
- •There were no deviations in this regard.
研究组 & 干预措施
1
Oxcarbazepine oral suspension 300 mg/5 mL of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceuticals Inc.)
干预措施: oxcarbazepine 300 mg/5 mL oral suspension (Drug)
2
Trileptal® (oxcarbazepine) oral suspension 300 mg/5 mL of Novartis
干预措施: oxcarbazepine 300 mg/5 mL oral suspension (Drug)
结局指标
主要结局
Bioequivalence evaluation of ranbaxy Oxcarbazepine oral suspension 300 mg/5mL under fed condition
次要结局
未报告次要终点