| CTRI Number |
CTRI/2024/11/077313 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
An Open Label Study Single Dose Crossover Oral Bioequivalence Study Comparing Dexamfetamine Sulfate 5 mg Tablets |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0067-24-DEXA Version 02 Dated 12 Sep 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 |
08220586899 |
| 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 |
08220586899 |
| 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 |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Nova Pharmaceuticals Australasia Pty Ltd Suite 305 10 Norbrik Drive Bella Vista NSW Australia 2153 |
|
|
Primary Sponsor
|
| Name |
Nova Pharmaceuticals Australasia Pty Ltd |
| Address |
Suite 305 10 Norbrik Drive Bella Vista NSW Australia 2153 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore 641029 Tamil Nadu India |
|
|
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 Life science and Research private limited |
Clinical Pharmacology unit
Ground Floor
Door No 29 A
Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU |
08220586899
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 Condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aspen Dexamfetamine Sulfate 5 mg Tablets |
Single Oral Dose of Dexamfetamine Sulfate 5 mg Tablets Will Be administered in each Period Total Duration is 11 Days |
| Intervention |
Dexamfetamine sulfate 5 mg Tablets |
Single Oral Dose of Dexamfetamine Sulfate 5 mg Tablets Will Be administered in each Period Total Duration is 11 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
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 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 |
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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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
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 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
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 |