CTRI/2024/08/072621已完成不适用
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioequivalence Study Comparing Epilkine 500 Mg Sr Tablets Sodium Valproate 333 Mg And Valproic Acid 145 Mg Equivalent To 500 Mg Of Sodium Valproate Manufactured By Sarl Novapharm Trading Algeria With Depakine® Chrono 500 Mg Prolonged Release Tablets Sodium Valproate 333 Mg And Valproic Acid 145 Mg Equivalent To 500 Mg of Sodium Valproate Manufactured By Sanofi Winthrop Industrie France In Healthy Adult Human Subjects Under Fasting Conditions
Sarl Novapharm Trading1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年8月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To assess the Bioequivalence on Epilkine 500 mg SR tablets Sodium Valproate 333 mg and Valproic Acid 145 mg equivalent to 500 mg of Sodium Valproate Manufactured by Sarl Novapharm Trading Algeria With Depakine® Chrono 500 mg Tablets Sodium Valproate 333 mg and Valproic Acid 145 mg equivalent to 500 mg of Sodium Valproate Manufactured by Sanofi Winthrop Industrie France in Healthy Adult Human Subjects Under Fasting Conditions
研究概览
简要总结
“Enough volunteers shall be recruited in order to evaluate and start the study with at least 36 subjects, as this Bioequivalence study will be conducted on Healthy, Adult, Human Subjects Under Fasting Conditions.
As per the discretion of Investigator, additionally a sufficient number of stand-by subjects will be included to ensure successful dosing of 36 subjects in period I.
Note: Study will be conducted in two groups.
In each period subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 72.00 hours post-dose. A washout period of at least 07 days will be maintained between each dosing period.
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
- Male
入选标准
- •Normal healthy adult human subjects of age between 18 To 45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 30.00 kg/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 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 Non smokers Generally healthy as documented by gynaecological examination and breast examination for female subjects period I only.
排除标准
- •Evidence of allergy or known hypersensitivity to Sodium Valproate and Valproic Acid 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 or Xanthine containing products 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 any unusual diet for whatever reason 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 study period Positive results for alcohol test prior to check-in of each period Any blood donation 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.
结局指标
主要结局
To assess the Bioequivalence on Epilkine 500 mg SR tablets Sodium Valproate 333 mg and Valproic Acid 145 mg equivalent to 500 mg of Sodium Valproate Manufactured by Sarl Novapharm Trading Algeria With Depakine® Chrono 500 mg Tablets Sodium Valproate 333 mg and Valproic Acid 145 mg equivalent to 500 mg of Sodium Valproate Manufactured by Sanofi Winthrop Industrie France in Healthy Adult Human Subjects Under Fasting Conditions
时间窗: 00.50 Hrs 01.00 Hrs 02.00 Hrs 03.00 Hrs 04.00 Hrs 04.50 Hrs 05.00 Hrs 05.50 Hrs 06.00 Hrs 06.50 Hrs 07.00 Hrs 07.50 Hrs 08.00 Hrs 09.00 Hrs 10.00 Hrs 12.00 Hrs 16.00 Hrs 24.00 Hrs 36.00 Hrs 48.00 Hrs 72.00 Hsr 96.00 hrs 120.00 Hrs
次要结局
- To monitor the safety and tolerability of test Product Comparing With The Reference Product Administered In Healthy Adult Human Subjects Under Fasting Conditions(00.50 Hrs 01.00 Hrs 02.00 Hrs 03.00 Hrs 04.00 Hrs 04.50 Hrs 05.00 Hrs 05.50 Hrs 06.00 Hrs 06.50 Hrs 07.00 Hrs 07.50 Hrs 08.00 Hrs 09.00 Hrs 10.00 Hrs 12.00 Hrs 16.00 Hrs 24.00 Hrs 36.00 Hrs 48.00 Hrs 72.00 Hsr 96.00 hrs 120.00 Hrs)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited
研究点 (1)
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