None listed
Conditions
Interventions
Intervention1: 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
Control Intervention1: Aspen Dex
Sponsors
Nova Pharmaceuticals Australasia Pty Ltd
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ConditionsTimepoint: 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
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human male and female subjects under fasting conditionsTimepoint: 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 | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and research private limited
Outcome results
None listed