An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioequivalence Study Comparing Dexamfetamine Sulfate 5 mg Tablets Manufactured by Unison Pharmaceuticals Pvt Ltd with Aspen Dexamfetamine Sulfate 5 mg Tablets Manufactured by Aspen Pharmacare Australia Pty Ltd in Healthy Adult Human Male and Female Subjects Under Fasting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the Bioequivalence on Dexamfetamine Sulfate 5 mg Tablets
研究概览
简要总结
At least 24 number of healthy adult human 12 male and 12 female subjects will be recruited to evaluate the bioequivalence of Test product with the Reference product
As per the discretion of Investigator a sufficient number of stand by subjects will be included additionally to ensure successful dosing of 24 subjects in period I alone
In each period subjects will be housed in the clinical facility for at 11 00 hours pre-dose to 48 00 hours post dose A washout period of at least 07 days will be maintained between each dosing period
After an overnight fasting of at least 08 00 hours in the morning a single oral dose of either test product T or reference product R as per randomization schedule will be administered with 240 mL of drinking water at ambient temperature
Blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded at pre dose 00 00 hour within 75 minutes of before dosing and at 01 00 hrs 04 00 hrs 08 00 hrs 12 00 hrs 24 00 hrs and 32 00 hrs plus or minus 60 minutes post dose
Physical examination and vitals will be recorded before check in and check out 48 00 hours of each period and at any time if necessary
ECG will be recorded before check out 48 00 hours of each period or after any subject is withdrawn or dropped out during the study
Monitoring for adverse events will be done throughout the study period in clinical phase
研究设计
- 研究类型
- Interventional
- 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
- •Normal healthy adult human male and female subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg per m2 to 30.00 kg per m2 Subjects who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination including but may not be limited to an evaluation of the cardiovascular gastrointestinal System respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments Willing to consume Ovo lacto vegetarian diet Willing to comply to all requirements of this study protocol as well as instructed by the study personnel Nonsmokers Generally healthy as documented by gynaecological examination and breast examination for female subjects period I only Females of childbearing potential must have a negative serum pregnancy test perfonned within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period.
排除标准
- •Evidence of allergy or known hypersensitivity to Dexamfetamine Sulfate or its inactive ingredients Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease Any major illness in the last three months or any significant ongoing chronic medical illness Renal or liver impairment Any disease or condition which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and lor Xanthine containing products ie coffee tea chocolate and caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours prior to check in and throughout the entire study Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within 48 00 hours prior to clinic admission and throughout the entire study Subjects who have taken any prescription medications within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check in and throughout the study Subjects who have taken an unusual diet, for whatever reason (e.g. low salt) for 48 00 hours prior to dosing and throughout the study Subject who had participated in any other study within the 90 days of check in History of difficulty in swallowing History of difficulty in accessibility of veins Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check-in of this each period Positive results for alcohol test prior to check in of each period Any blood donation or excess blood loss within 90 days of check in Ingestion of any hormonal agent at any time within 14 days prior to start of study check in Use of hormone replacement therapy for a Period of 06 months prior to dosing Female subjects demonstrating a positive pregnancy screen Female subjects who are currently lactating Females likely to become pregnant during conduction of the study.
结局指标
主要结局
To assess the Bioequivalence on Dexamfetamine Sulfate 5 mg Tablets
时间窗: 16 00 Time points | 00 00 Hrs 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 50 Hrs 03 00 Hrs 03 50 Hrs 04 00 Hrs 05 00 Hrs 08 00 Hrs 12 00 Hrs 16 00 Hrs 24 00 Hrs 32 00 Hrs 48 00 Hrs
Manufactured by Unison Pharmaceuticals Pvt Ltd with Aspen Dexamfetamine Sulfate 5 mg Tablets Manufactured by Aspen Pharmacare Australia Pty Ltd in Healthy Adult Human Male And Female Subjects Under Fasting Conditions
时间窗: 16 00 Time points | 00 00 Hrs 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 50 Hrs 03 00 Hrs 03 50 Hrs 04 00 Hrs 05 00 Hrs 08 00 Hrs 12 00 Hrs 16 00 Hrs 24 00 Hrs 32 00 Hrs 48 00 Hrs
次要结局
- To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human male and female subjects under fasting conditions(16 00 Time points)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited