None listed
Conditions
Interventions
Intervention1: Lisdexamfetamine Capsules 70 mg: Dose: 70mg
Frequency: Single dose, two period
Route of administration: Oral
Study duration: 09 days with washout period of 5 days
Control Intervention1:
Sponsors
Granules India Limited, India
Zenrise Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy, adult, humans aged between 18 to 45 years (inclusive of both). 2. Body mass index between 18.50-30.00 kg/m2 (inclusive of both) and weight 45 kgs. 3. Healthy according to the laboratory results and physical examination, performed within 28 days prior to the commencement of the check-in of Period-I. 4. Non-smoker and non-alcoholics. 5. Normal 12-lead electrocardiogram (ECG). 6. Normal chest X- Ray (P/A view). 7. Able to communicate effectively. 8. Normal values in the assessment of depression using depression scale during check-in of period - I. 9. Willing to give written informed consent and adhere to protocol requirements as evidenced by written informed consent approved by an Ethics Committee (EC). 10. Male trial participant who is willing to use effective contraception methodsfor the duration of the study as judged by the investigator(s) 11. Female trial participant who is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s),Or is postmenopausal for at least 1 year Or Is surgically sterile
Exclusion criteria
Exclusion criteria: Trial participants will not be eligible for study participation if any of the following criteria is met: 1.History of contraindications or hypersensitivity to Lisdexamfetamine or any of the excipients in the formulation. 2.Tested positive for VDRL, HIV (1 & 2) Antibodies, HbsAg (Hepatitis B Surface Antigen) and HCV Antibodies during serologic tests. 3.History or presence of significant cardiovascular (angioedema etc.,), pulmonary, hepatic, renal (severe renal insufficiency etc.,), gastrointestinal, endocrine, immunological, ophthalmic, infectious, metabolic, hematological, dermatological, neurological or psychiatric disease (epilepsy, depression, severe anxiety, or psychosis etc.,) or any significant medical condition or disease according to the opinion of the physician. 4.Who are on strong CYP3A4 and CYP2D6 inhibitors or inducers, Antihypertensives, Ascorbic acid, Sodium bicarbonate, antipsychotics and serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) 5. Any family history of bipolar disorder, suicide, or depression. 6. History or presence of significant drug abuse in the past one year. 7. Usage of any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study. 8. Having surgical treatment history or a plan within one week prior to the first dose or after the last dose. 9. Difficulty with donating blood or difficulty in accessibility of veins. 10. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in. 11. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg. 12. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. 13. Pulse rate less than 60 beats/minute or more than 100 beats/minute. 14. Usage of any prescribed medication, MAO inhibitors, herbal medications and OTC medicinal products during the last 14 days preceding the first dosing. 15. Major illness during 90 days before screening. 16. Participation in a drug research study within past 90 days. 17. Donation of blood in the past 90 days prior to study check-in of period-I. 18. Male trial participant who is not willing to use effective contraception methods for the duration of the study as judged by the investigator(s) 19. Female trial participant who is pregnant or lactating or breast-feeding. Or Having Amenorrhea during past 6 months Or Having unprotected sex with any nonsterile male partner within 14 days and unwilling to follow the entire duration of the study.Or Tested positive for serum beta hCG test at the time of check-in.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of Test product (T), Lisdexamfetamine Capsules 70 mg of Granules India Limited, India and Reference product (R), Elvanse (lisdexamfetamine) 70 mg Hard Capsules of Takeda Pharmaceuticals International AG Ireland Branch, Ireland in normal, healthy, adult, human trial participants under fasting condition.Timepoint: Pre-dose to 48.00 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of Lisdexamfetamine Capsules 70 mg in normal, healthy, adult, human trial participants.Timepoint: Pre-dose to 48.00 hours post dose | — |
Countries
India
Contacts
Public ContactMr S Sri Harsha
ZenRise Clinical Research Private Limited
Outcome results
None listed