| CTRI Number |
CTRI/2024/08/072621 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0007-24-VALP version 02 Dated 27 Jul 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit
Ground Floor
29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit
Ground Floor
29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit
Ground Floor
29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
|
BDR Pharmaceuticals International Private Limited Engineering Centre 6th Floor 9 Mathew Road Opera House Mumbai 400004 |
|
|
Primary Sponsor
|
| Name |
Sarl Novapharm Trading |
| Address |
152 route de Kolea Bouismail
Tipaza 42026 Algeria
North Africa
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
29 A Krishna Maduravanam Vellakinar Pirivu thydiyalur Coimbatore 641029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep T |
Spinos Lifescience and research private limited |
Clinical Pharmacology unit
Ground Floor
29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur
Coimbatore
TAMIL NADU |
8220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting Conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Depakine® Chrono 500 Mg |
Prolonged Release Tablets Sodium Valproate 333 Mg And Valproic Acid 145 Mg Equivalent To 500 Mg of Sodium Valproate Oral dose single administration |
| Intervention |
Epilkine 500 Mg Sr Tablets |
Sodium Valproate 333 Mg And Valproic Acid 145 Mg Equivalent To 500 Mg Of Sodium Valproate Oral dose single administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2024 |
| Date of Study Completion (India) |
30/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
“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. |