An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose, oral bioequivalence study of Carbidopa 61.25 mg and Levodopa 245 mg Extended Release Capsules (T) Manufactured by ScieGen Pharmaceuticals, Inc 89 Arkay Drive, Hauppauge, New York- 11788, United States with RYTARY® (Carbidopa and Levodopa) Extended Release Capsules 61.25 mg/ 245 mg (R) Manufactured by Bora Pharmaceutical Laboratories Inc. Jhunan, Taiwan and Distributed by Amneal Specialty, a division of Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 in normal healthy, adult male and female subjects under fed and fasting condition.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Cmax, AUC(0-t) and AUC(0-inf)
概览
简要总结
After an overnight fasting of at least 10.00 hours and exactly 30 minutes after serving of high fat, high calorie non-vegetarian breakfast, a single dose of Carbidopa 61.25 mg and Levodopa 245 mg Extended Release Capsules (T) Manufactured by ScieGen Pharmaceuticals, Inc 89 Arkay Drive, Hauppauge, New York- 11788, United States or RYTARY® (Carbidopa and Levodopa) Extended Release Capsules 61.25 mg/ 245 mg (R) Manufactured by Bora Pharmaceutical Laboratories Inc. Jhunan, Taiwan and Distributed by Amneal Specialty, a division of Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 along with 240±2 mL of water, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Subjects will receive the alternate ‘treatment’ in the subsequent periods, in such a way that each subject will have received “all the treatments (T and R) once†by the end of the study
研究设计
- 研究类型
- Ba/be
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Volunteers who accept for participating in this study must be:
- •Healthy, adult male and female, subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening.
- •Having a Body Mass Index (BMI) between 18.50 to 29.99 kg/m2 (both inclusive) at the time of screening.
- •Normal or clinically insignificant findings during screening, medical history, clinical examination including vital signs, laboratory evaluations, 12 lead ECG and X-ray chest (posterior-anterior view) recordings.
- •Able to comply with the study procedures, in the opinion of the Principal Investigator.
- •Compliance with study specific restrictions and prohibitions.
- •Able to give voluntary written informed consent for participation in the trial.
- •In case of Female subjects:
- •Female subjects who are of child bearing potential and are willing to use a suitable and effective double barrier contraceptive method or non-hormonal intra uterine device during the study.
- •Female subjects who are tested negative for serum pregnancy test at the time of check-in.
排除标准
- •If any subject is having any of the following conditions, will be excluded from the participation in this study:
- •Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
- •History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.
- •History of significant daytime sleepiness or episodes of falling asleep during activities.
- •Ingestion of any medicine at any time within 14 days prior to IP administration in period I.
- •In any such case subject selection will be at the discretion of the Principal Investigator.
- •Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
- •Smokers and Alcoholics.
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
- •An unusual or abnormal diet within 48.00 hours prior to study check-in, whatever reason e.g. because of fasting due to religious reasons.
结局指标
主要结局
Cmax, AUC(0-t) and AUC(0-inf)
时间窗: Total 23 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 4.0 mL will be collected and placed in Ice cold bath at each period. | The post-dose blood samples of 4.0 mL will be collected and placed in Ice cold bath at 00.33, 00.68, 01.00, 01.33, 01.68, 02.00, 02.33, 02.68, 03.00, 03.33, 03.68, 04.00, 04.33, 04.68, 05.00, 05.50, 06.00, 08.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose.
次要结局
- Tmax, t½, Kel, Kel Lower, Kel Upper and AUCExtrapolated%(Total 23 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 4.0 mL will be collected and placed in Ice cold bath at each period.)
研究者
Dr Divya A MD
M/s Notrox Research Pvt Ltd (NRPL)